CN107847709A - Melted with the arteria carotis barrier film of ultrasonic imaging and ablation catheter - Google Patents

Abstract

Reduced and inputted to the chemical sensor of nervous system to assess and treat the method and apparatus of the patient for the disease that the sympathetic nerve for the sympathetic tone for reflecting and increasing with the peripheral chemoreceptor for being related to enhancing mediates by carotid body ablation.

Description

Melted with the arteria carotis barrier film of ultrasonic imaging and ablation catheter

The cross reference of related application

The priority for the 62/132nd, No. 459 U.S. Provisional Application submitted this application claims on March 12nd, 2015, it is public Cloth content is incorporated herein by reference.

It is incorporated by reference into

The application is incorporated by reference into following U.S. Provisional Application：The application number 61/952 that on March 12nd, 2014 submits, 015；The application number 62/017,148 that on June 25th, 2014 submits；The application number 62/049 submitted for 12nd with September in 2014, 980。

Apply below also by being incorporated herein by reference：The U.S. Publication No 2014/0005706 that on January 2nd, 2014 announces； The U.S. Publication No 2014/0350401 announced with November 27th, 2014.

The all publications and patents application mentioned in this manual is incorporated herein by reference, and it is incorporated by reference into This paper degree just as each individually publication or patent application are specifically and individually indicated be incorporated by reference into it is identical Degree.

Technical field

Present disclosure is related generally to by melting a carotid body, two carotid bodies and god associated there At least one treatment in is lived with the sympathetic nerve for reflecting or increasing with the peripheral chemoreceptor of enhancing at least in part Change the system and method for the patient of the disease of associated sympathetic nerve mediation.

Background

, it is known that autonomic nerves system is unbalance associated with various disease states.The recovery of autonomic balance has turned into a variety of The target of therapeutic treatment, the plurality of medical treatment include such as pharmacy, form based on equipment and electro photoluminescence.Example Such as, Bextra (beta blockers) is a kind of for reducing sympathetic nerve activity to treat cardiac arrhythmia and height The medicine of blood pressure；Gelfand and Levin (US 7,162,303), which is described, be used to reduce renal sympathetic nerve discharge to treat the heart The treatment based on device of force failure, hypertension and kidney failure；Yun and Yuarn-Bor (US 7,149,574；US 7,363, 076；US 7,738,952) describe and recover autonomic balance by increasing parasympathetic activity to treat and parasympathetic nerve damage The method of the associated disease of consumption；Kieval, Burns and Serdar (US 8,060,206) describe to be stimulated in response to hypertension Pressoreceptor, increase the electric pulse generator of parasympathetic activity；Hlavka and Elliott (US 2010/0070004) Describe connected with the afferent nerve path of chemical receptor of carotid body with by electric nerve adjustment control is dyspneic can The egersimeter of implantation.Recently, carotid body ablation (CBA) is contemplated for treating the disease of sympathetic nerve mediation.

General introduction

Present disclosure is related to for reducing the conduction of the input signal between peripheral chemoreceptor and central nervous system Methods, devices and systems.Method of the present disclosure including the targeted energy ablation for carotid body or its related neural, Device and system.Particularly, for suitable for the intravascular carotid body ablation catheter ablation tissue to being imaged and melting such as The neural method and dress of carotid body, arteria carotis barrier film or close the blood vessel such as vein or artery related to carotid body Put.

Present disclosure is a kind of side of the tissue using in supersonic melting catheter ablation arteria carotis barrier film on one side Method, including：Supersonic melting conduit is provided, it includes diagnostic ultrasound transducer and supersonic melting transducer, and the diagnostic ultrasound changes Energy device is axially spaced with the supersonic melting transducer and has fixed position relative to the supersonic melting transducer；It will disappear Melt catheter positioning in patient's vascular system in the tube chamber of arteria carotis barrier film；Dissection is produced using diagnosing image transducer The ultrasonoscopy of mark is learned, the anatomic landmarks include at least one in arteria carotis communis bifurcated, internal carotid and external carotid artery It is individual；Confirm supersonic melting transducer in intraluminal ablation locations using the anatomic landmarks of imaging；With change when supersonic melting Can device when being in ablation locations, the tissue supersonic melting energy from supersonic melting transducer being directed in arteria carotis barrier film To melt the tissue in arteria carotis barrier film and treat at least one of heart failure and hypertension.

In some embodiments, diagnostic ultrasound transducer supersonic melting transducer near-end, and using diagnosis into The ultrasonoscopy of anatomic marker is generated including the use of the super of diagnosing image transducer generation arteria carotis communis bifurcated as transducer Acoustic image, and wherein confirm that supersonic melting transducer includes making in intraluminal ablation locations using the anatomic marker of imaging Confirm supersonic melting transducer in intraluminal ablation locations with the arteria carotis communis bifurcated of imaging.

In some embodiments, diagnostic ultrasound transducer is in the distal end of supersonic melting transducer, and using diagnosis into The ultrasonoscopy of anatomic landmark is generated including the use of diagnosing image transducer generation internal carotid and external carotid artery as transducer At least one ultrasonoscopy, and wherein using imaging anatomic landmark confirm supersonic melting transducer disappear intraluminal Melt position including the use of the arteria carotis of at least one imaging to confirm supersonic melting transducer in intraluminal ablation locations.

In some embodiments, positioning step includes ablation catheter being positioned in one of jugular vein or its tributary simultaneously And at arteria carotis barrier film, and wherein confirm ablation catheter in intraluminal ablation locations using the anatomic marker of imaging Anatomic marker including the use of imaging confirms ablation locations of the ablation catheter in one of jugular vein or its tributary.This method Can also include by reconfigure the conduit in one of jugular vein or its tributary with move supersonic melting transducer closer to Arteria carotis barrier film targets arteria carotis diaphragm tissue to be ablated.

In some embodiments, this method also includes melting transducer by rotary ultrasonic as needed so that ultrasound to be disappeared Melt the tissue that energy is aimed in arteria carotis barrier film to treat by the arteria carotis diaphragm tissue of supersonic melting energy ablation to target.Using into The anatomic marker of picture confirms that supersonic melting transducer can be including the use of the anatomy of imaging in intraluminal ablation locations Mark confirms the sighted direction of supersonic melting energy.

In some embodiments, this method also includes waiting to be surpassed to target by controlling supersonic melting energy transportation parameters The arteria carotis diaphragm tissue of sound ablation energy ablation.

Present disclosure is supersonic melting conduit on one side, and it includes：Supersonic melting transducer, Ultrasonic Diagnosis transducing Device and anechoic room (echolucent chamber), the supersonic melting transducer and the Ultrasonic Diagnosis transducer axes to Separate and there is fixed position relative to the Ultrasonic Diagnosis transducing, and the supersonic melting transducer is arranged on the nothing and returned In sound chamber.

In some embodiments, conduit also includes the fluid conveyor chamber being in fluid communication with anechoic room.

In some embodiments, anechoic room includes film and manifold, and wherein manifold includes cavity.

In some embodiments, Ultrasonic Diagnosis transducer includes setting around the circumference of conduit but is not arranged in circumference Multiple ultrasonic imaging transducers of the upper position opposite with the sighted direction of supersonic melting transducer.

In some embodiments, Ultrasonic Diagnosis transducer includes the multiple ultrasonic imaging transducings set around conduit circumference Device.Conduit can also include being arranged on the supravasal imaging artefacts opposite with the sighted direction of supersonic melting conduit.

In some embodiments, supersonic melting transducer is located at the distal end of Ultrasonic Diagnosis transducer.

In some embodiments, supersonic melting transducer is located at the near-end of Ultrasonic Diagnosis transducer.

In some embodiments, conduit also includes the expandable membrane with deployed condition, and wherein expandable members ratio is outer Conduit sheath, which is diametrically prolonged, to be projected farther.

In some embodiments, anechoic room is included with multiple films perforated and therefrom penetrated.

In some embodiments, conduit also includes guidewire lumen.

In some embodiments, Ultrasonic Diagnosis transducer is rotary ultrasonic diagnostic transducer.

Present disclosure is the method being imaged to the sighted direction of supersonic melting transducer on one side, including： Supersonic melting conduit is provided, it includes supersonic melting transducer and diagnostic ultrasound transducer, and the supersonic melting transducer is with examining Disconnected ultrasonic transducer is axially spaced and has fixed position relative to the diagnostic ultrasound transducer；Changed from the supersonic melting Can the non-ablative ultrasonic signal of device transmitting；And using the diagnostic ultrasound transducer to the non-ablative ultrasonic signal and extremely A few anatomic marker is imaged, so as to be directed at least one anatomic marker to the supersonic melting transducer Sighted direction is imaged.

In some embodiments, this method also includes sending to both diagnostic ultrasound transducer and supersonic melting transducer Synchronizing signal.

In some embodiments, supersonic melting transducer has the resonant frequency different from diagnostic ultrasound transducer.

In some embodiments, this method also includes rotary ultrasonic ablation transducer, until the non-ablation letter launched Number it is drawn towards destination organization.

In some embodiments, at least one anatomic marker is internal carotid, external carotid artery, carotid bifuracation and neck It is at least one in total artery.

Brief description

Fig. 1 is depicted in simplified schematic form inserts intravascular oriented energy ablation catheter via femoral venous puncture Patient's body.

Fig. 2 be show some characteristic sizes by arteria carotis spacer film (intercarotid septum) and surrounding group The schematic diagram for the cross section knitted.

Fig. 3 A, 3B, 3C, 3D and 3E are the schematic diagrames of the embodiment of ultrasonic transducer.

Fig. 4 A and 4B are the schematic diagrames for the Ultrasonic C BA conduits for being transported to jugular vein.

Fig. 5 A, 5B, 6A, 6B, 7A, 7B, 7C, 8A, 8B, 8C and 8D are the ultrasounds for having one or more diagnostic catheters The schematic diagram of CBA conduits, the diagnostic catheter are used to be aligned with being transported to the vessel landmarks of jugular vein.

Fig. 9 A and 9B are the schematic diagrames of the Ultrasonic C BA conduits with adjustable focusing distance.

Figure 10 is the schematic diagram of the Ultrasonic C BA conduits with adjustable focusing distance.

Figure 11 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 12 A to 12I are configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 13 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 14 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 15 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 16 is the schematic diagram of the caused ultrasonoscopy in transvenous carotid body ablation procedure.

Figure 17 is the schematic diagram of deflectable ultrasound catheter.

Figure 18 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 19 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 20 is configured for receiving the schematic diagram of the Ultrasonic C BA conduits of single ultrasound imaging catheter.

Figure 21 A, 21B and 21C are the schematic diagrames of the CBA conduits and deflectable sheath that manipulate venous locations.

Figure 22 is configured for the schematic diagram of the transducer assemblies for melting and being imaged.

Figure 23 is configured for including the schematic diagram for the conduit for being used to being imaged and melting the transducer assemblies of the two.

Figure 24 A and 24B are figure of the lesion depths relative to energy.

Figure 24 C are the examples for determining the algorithm of the dosimeter of unique conduit.

Figure 25 is damage dose look-up table.

Figure 26 is the video based on ultrasound shot by the conduit being positioned towards in the jugular vein of carotid bifuracation One frame.

Figure 27 is the block diagram of the system for being imaged and melting.

Figure 28,29,30 and 31 are the schematic diagrames of the video based on ultrasound of enhancing.

Figure 32 is the schematic diagram of the pin type ablation catheter of ultrasonoscopy guiding.

Figure 33 is the schematic diagram of the pin type ablation catheter of ultrasonoscopy guiding.

Figure 34,35 and 36 are the schematic diagrames of the Ultrasonic C BA conduits with integrated ultrasonic imaging transducer array.

Figure 37 A are the schematic diagrames from the video based on ultrasound of the jugular vein shooting close to arteria carotis barrier film.

Figure 37 B are come from from the schematic diagram of the video based on ultrasound of the jugular vein shooting close to arteria carotis barrier film, display Melt the aiming transmitting of converter.

Figure 38 is the schematic diagram of the Ultrasonic C BA conduits with integrated ultrasonic imaging transducer.

It is described in detail

This disclosure is related to melt for carotid body suffers from the periphery by strengthening at least in part to treat Learn receptor reflection (for example, peripheral chemoreceptor hypersensitive, peripheral chemical sensor hyperactive) or the sympathetic god increased Disease (such as heart, kidney, metabolism or PUD D such as hypertension, CHF, the sleep mediated through sympathetic nerve caused by activation Apnea, sleep disordered breathing, diabetes, insulin resistance) patient systems, devices and methods.As used herein Carotid body ablation typically refers to melt one or two carotid body, carotid body nerve, arteria carotis interval completely or partially Film or peripheral chemoreceptor.Main therapy approach is to reduce peripheral chemoreceptor reflection or reduce to come from carotid body (CB) afferent nerve signals conduction, it causes the nervous reduction of central sympathetic.For the purpose of the application, carotid body is passed to Nerve is considered as the chemoreceptor reflex strengthened (regardless of its cause) higher than normal long-term or interval sexuality. Other important benefits, such as the increase of parasympathetic anxiety, particularly vagal tone and baroreflex and Baroreceptor Activity, The reduction of expiratory dyspnea, hyperventilation and respiratory rate, can be expected in some patients.Reduction secondary to respiratory rate, The nervous extra increase of parasympathetic can be expected in some cases.(such as neck moves for the peripheral chemoreceptor reflection of enhancing Arteries and veins body activates) cause the increase of stomodaeal nervous system activity, this then mainly cause see in target patient population it is chronic The progress and debilitating symptom and adverse events of disease.Carotid body includes the cell sensitive to oxygen and carbon dioxide.Neck moves Arteries and veins body is also reacted to blood flow, pH value of blood, blood sugar level and its possible dependent variable.Therefore even if chemical-sensitive is thin Born of the same parents are not activated, and carotid body ablation can also turn into the therapeutic scheme to patient, such as with hypertension, heart disease or diabetes Patient.

Target：

In order to suppress or suppress peripheric receptor chemoreceptor reflex, anatomic targets to be ablated (also referred to as target Tissue, target ablation position or target site) following at least a portion can be included：At least one carotid body, sustainer Body, the nerve associated with peripheral chemoreceptor (for example, carotid body is neural, carotid sinus nerve, carotid plexus), Support peripheral chemoreceptor small blood vessel, carotid body essence, chemical-sensitive cell (for example, blood vessel glomus cell), Tissue, arteria carotis in carotid body resident site (such as site based on preoperative imaging or anatomy possibility) under a cloud Spacer film, a part for arteria carotis spacer film, sizable a part of (a substantial part) of arteria carotis spacer film Or its combination.As used herein, the ablation of carotid body can refer to any one position in these target ablation positions Ablation.

Arteria carotis spacer film, arteria carotis barrier film is being also known as herein, be defined herein as tissue has with following The wedge shape on boundary or the section of triangle：The afterbody pattern that the saddle (saddle) of carotid bifuracation defines arteria carotis barrier film (pushes up Point)；The aspectant wall of internal carotid and external carotid artery defines the both sides of arteria carotis barrier film；The cranium lateral boundaries of arteria carotis barrier film exist Extend between these arteries and can be defined as the cranium side of carotid body, but may be in this region it is any important non- The caudal of target nerve structure (such as hypoglossal nerve), for example, cranium lateral boundaries can be the about 10mm of the saddle away from carotid bifuracation extremely About 15mm；The madial wall and lateral wall (medial and lateral walls) of arteria carotis barrier film are generally by approx tangential Defined in the plane of internal carotid and external carotid artery；A lateral wall for being tangential to internal carotid and external carotid artery in the plane And another plane is tangential to the madial wall of these arteries.Arteria carotis spacer film is arranged between madial wall and lateral wall.Neck Artery spacer film can completely or partially include carotid body, and important non-targeted structure can be not present, such as be confused Walk nerve or sympathetic nerve or hypoglossal nerve.Arteria carotis spacer film can include some pressoreceptors or pressoreceptor god Through.Arteria carotis spacer film may also include neuropile nerve, thin vessels and fat between arteria carotis.Arteria carotis spacer film can be ablation Target.Even if carotid body or carotid body nerve easily can not be identified visually specifically to target, arteria carotis Spacer film can be targeted, and had ablation carotid body and safely avoided non-targeted neural high probability.Can arteria carotis every Multiple ablations are produced in film to cover the tissue of increase volume to increase the ablation probability of carotid body.Multiple ablations can be with overlapping It is or discontinuous in arteria carotis barrier film.

Carotid body nerve is anatomically defined herein as carotid plexuses nerve and carotid sinus nerve.Neck moves Arteries and veins somatic nerves is functionally defined herein as information to be conducted from carotid body to the nerve of central nervous system.Neck moves Arteries and veins somatic nerves is properly termed as one or more nerves associated with carotid body herein.

Ablation can be concentrated exclusively on the target tissue, or concentrated on destination organization while safely melted close to target group The tissue (for example, to ensure that destination organization is ablated to or be used as the approach for obtaining the path to destination organization) knitted.Ablation areas Can be equally big with peripheral chemoreceptor (such as carotid body or aortic body) itself, it is somewhat smaller, or greatly and can more wrap Include one or more tissues around chemocepter, such as blood vessel, tunica adventitia of artery, manadesma, perfusion chemocepter is small Blood vessel and the nerve that is connected to blood vessel glomus cell and makes blood vessel glomus cell innervate.It understanding of some pressure experiences Device nerve will jointly be melted with carotid body nerve, then clump or carotid sinus nerve can be the mesh of ablation between arteria carotis Mark.Pressoreceptor is distributed in human arterial and the redundancy with high level.

Tissue can be ablated to anti-to suppress or suppress the chemocepter of the only one in the two of patient carotid bodies Penetrate.Other embodiments include ablation tissue to suppress or suppress the chemoreceptor reflex of the two of patient carotid bodies. In some embodiments, the first carotid body is melted, is then assessed and is moved with determining whether melt another neck Arteries and veins body.For example, treatment method can include melting a carotid body, chemosensitivity, sympathetic nerve obtained by measuring Activity, breathing or the other specification related to carotid body hyperactive, and if it is desire to further after the ablation of one side The ablation of the second carotid body can then be carried out by reducing chemosensitivity.

The pressure that the embodiment for the treatment of can substantially reduce chemoreceptor reflex and not excessively reduce patient is anti- Penetrate.Proposed ablative surgery can be being moved with substantially avoiding carotid sinus, being distributed in arteria carotis particularly in neck for targeting At least some of carotid sinus nerve of the signal of pressoreceptor and conduction from the pressoreceptor in the wall of arteries and veins. For example, baroreflex can be by substantially avoiding below targetting：The possibility of limited bulk surrounds being ablated to for carotid body Tissue, the tissue comprising large number of carotid body nerve, the tunica adventitia of artery of inner side section at carotid bifuracation Tissue in all spaces (periadventitial space) or the tissue positioned at carotid body and the attachment position of artery. The ablation of the targeting by by the region or carotid body itself the Visual Implementation, such as by CT, CT angiography, MRI, ultrasonography, fluoroscopy, by blood flow visualization or the injection of contrast agent and instrument is positioned at neck Position, while avoided to arteria carotis, pressoreceptor, carotid sinus nerve or other weights in artery body or close to carotid body The excessive damage that the non-targeted nerve wanted for example is predominantly located at the vagus nerve or sympathetic nerve on the outside of arteria carotis barrier film (such as wears Hole, narrow, thrombosis).Therefore, it is probably helpful in the following areas to carotid body imaging before ablation：(a) select Candidate is selected, if there is carotid body, sufficiently large and if being identified to, and (b) guiding treatment, by for operator It is tight to arteria carotis barrier film, the center of arteria carotis barrier film, carotid body nerve, blood vessel so that ablation instrument is guided to provide mark collection of illustrative plates Region or it is contemplated that the region of carotid body itself or carotid body nerve adjacent to carotid body.Its row of may also help in Except wherein carotid body is located substantially on the outside of arteria carotis barrier film, in position close to vagus nerve, hypoglossal nerve, jugular vein or Some others can be ablated to the patient of the structure injured.In one embodiment, only carotid body is located substantially on Patient in arteria carotis spacer film is selected for ablation therapy.

Once carotid body is ablated to, removes or denervation, then carotid body function (such as carotid body chemoreception Device reflects) it basically can not recover in the mankind, partially due to aortic chemoreceptor is considered as not fill in the mankind What distribution was educated.On the contrary, once carotid sinus pressure reflection is removed, then it is generally by sustainer after several all or several month Or the pressoreceptor baroreflex compensation of other arteries.Therefore, if carotid chemoreceptor reflection and baroreflex two Person is removed or significantly reduced, such as by cutting off neuropile nerve, baroreflex between carotid sinus nerve or arteria carotis It can be finally recovered, and chemoreceptor reflex cannot.The consequence of the temporary removal or reduction of baroreflex is at certain It is probably that relatively serious and needs are in hospital and controlled using medicine in the case of a little, but they are not usually threat to life , it is not controlling or permanent.It will be understood, therefore, that although the selective removal and pressure of chemical receptor of carotid body reflection are anti- The reservation penetrated is probably desired, but may not be indispensable in some cases.

Ablation：

Term " ablation " can refer to change tissue and (be greater than 3 weeks, more than 6 with the period for good and all or persistently extended Individual month, more than 1 year, continue several years or continue patient's remaining years) compacting or suppress its biological function or activity in response to stimulation. The denervation of selectivity can relate to, for example, interrupting the afferent nerve from carotid body substantially retains conduction pressure simultaneously The nerve from carotid sinus adjacent with other the neural such as hypoglossal nerve, laryngeal nerve of ergoreceptor signal and it is confused absent-minded Through.Selectivity denervation another example can relate to interrupt carotid sinus nerve or with carotid body and some pressures Clump between the arteria carotis that both ergoreceptors connect, wherein the chemoreceptor reflex from carotid body for good and all or is persistently prolonged The long period (such as several years) is reduced and baroreflex is substantially extensive within the short period (such as a few days or several weeks) It is multiple.As used herein, term " ablation " or its derivative refer to suppress or suppress natural chemocepter or afferent nerve The Invasive procedures of function, this is adjusted with electric nerve or reversibly inactivation and reactivation chemoreceptor function are contrasted.

Carotid body ablation (" CBA ") used herein refers to such destination organization ablation, and wherein intended effect is Reduce or remove the afferent nerve signals conduction from chemical sensor (such as carotid body) or reduce chemoreceptor reflex. Because chemoreceptor reflex or afferent nerve activity can not be with practical way direct measurements, therefore can transfer to make sometimes With the index such as chemosensitivity of chemoreceptor reflex.Chemoreceptor reflex is reduced generally by the reduction of blood pressure, ventilation Increase and the reduction made great efforts of taking a breath of per unit blood gas concentration, saturation pressure or partial pressure change are indicated or by that can survey indirectly The reduction instruction of the central sympathetic activity of amount.Sympathetic activity can by blood pressure, lead to the peripheral nerve of muscle (MSNA) measurement activity, heart rate (HR), HRV (HRV), hormone such as feritin, adrenaline and angiotensin Produce and the reduction of peripheral vascular resistance is assessed.All these parameters are measurable and can lead directly to health Improve.In the case of CHF patient, blood pH, blood PCO₂, hyperventilation degree and metabolism exercise test parameter such as peak Value VO₂And VE/VCO₂Slope is also important.It is believed that as being for example short of breath and low blood CO₂Result, have it is elevated The patient of chemoreceptor reflex has low VO₂With high VE/VCO₂Slope (index of the effciency of respiratory).These parameters also with motion Limit relevant, these motion limitations further speed up patient towards morbidity and the state deteriorating in dead direction.It is it should be understood that all These indexs be indirect and faulty, and be intended to instruct successful to the most possible technology be benefited or obtain ablation The treatment of the patient of instruction, without being intended to prove the accurate measurement to effect or ensureing successfully.It has been observed that heart patient In some tachyarrhythmias be sympathetic nerve mediation.Therefore, reversible auricular fibrillation is being treated in carotid body ablation It may be helpful with ventricular tachycardia.

Carotid body ablation can include being used for heat by thermal heat mechanism (thermal heating mechanism) The method and system of ablation tissue.Due to the direct effect to tissue and structure of thermal stress induction, heating ablation can be implemented.Separately Other places or selectively, calorifics, which destroys, may be at least partially due to blood vessel or circumvascular structure (such as artery, petty action Arteries and veins, capillary or vein) change caused by, these structures perfusion carotid body and surround carotid body and make carotid body by The nerve fibre (such as afferent message is transmitted to the nerve of brain from chemical receptor of carotid body) of innervation.Additionally Or selectively, calorifics, which destroys, can be due to agglutination, fibrosis or be organized in caused by scabbing after fire damage, Particularly when it is expected to prevent the regrowth and regeneration of active mass.As used herein, the calorifics mechanism for ablation can be with Including both thermal necrosis and fire damage or infringement (for example, passing through continuous heating, Convective Heating, resistance heating or its any group Close).Thermal heat mechanism can include moving destination organization, such as nerve fibre, chemosensitive cell, whole or substantial amounts of neck Arteries and veins body cell and the temperature of perfusion carotid body or its neural thin vessels are elevated above desired threshold value, for example, being higher than About 37 DEG C of body temperature, for example, to realize fire damage or infringement, or it is elevated above about 45 DEG C of temperature (such as greater than about 60 DEG C), continue the known time for causing essentially non-reversible ablation at a temperature of gained to realize thermal necrosis.

In addition to raising temperature during heating ablation, influence heat can be designated as on the time span of thermostimulation exposure and disappeared The degree or degree for the effect of melting.In some embodiments, the time span exposed to thermostimulation be about 1 second and about 60 seconds it Between, between e.g., from about 5 seconds and about 30 seconds.In some embodiments, the time span of thermostimulation exposure can be longer than or is waited It is longer than in about 30 seconds or even or equal to about 2 minutes.In addition, exposure time span can less than or equal to about 10 minutes, but It is the upper limit that this is not construed as open-assembly time section.Temperature threshold or thermal dose can continue as to thermostimulation exposure The function of time is determined.Additionally or alternatively, exposed time span can be as the function of desired temperature threshold It is determined.The parameter of these and other can be designated or be calculated to realize and control desired heating ablation.The ablation of thermal induction Can be by indirect to destination organization, such as nerve fibre, chemosensitive cell and whole or substantial amounts of carotid body cell Produce or apply heat energy to realize, such as by being focused on to target neural fiber application high intensity focused ultrasound (HIFU), part Ultrasound or high-strength directional ultrasound.

Carotid body ablation can include whole body conveying medicament and by energy such as ultrasonic energy be directed to carotid body or Related neural causes carotid body or related neural to be damaged to activate the medicament.

Other and selectable method and apparatus, which can be used for realizing, to be melted.

Oriented energy embodiment

Fig. 1 depicts blood vessel interior orientation with femoral venous puncture device 17 by intravascular method in simplified schematic form The optional embodiment that energy ablation conduit 13 is inserted in the body of patient 1.The distal end of intravascular oriented energy ablation catheter 13 is (with void Line is shown) it is depicted in left jugular vein 12 (shown in broken lines), at the horizontal plane of left neck artery bifurcated 2, it is arranged to It is easy to the oriented energy of arteria carotis to melt.As shown, by intravascular oriented energy ablation catheter 13 inserting near groin Enter inserted into the patient at position 17, enter femoral vein 16 and to advance through inferior caval vein 15, superior vena cava 14, left neck always quiet Arteries and veins 11 simultaneously enters left jugular vein 12.It is alternatively possible to insertion site is selected to be obtained across brachial vein, subclavian vein, neck The venous channel of total vein 11 or any suitable peripheral vein.In addition, depending on the specific blood vessel of patient 1 and neurotomy Learn, the distal end of intravascular oriented energy ablation catheter 13 can be positioned for carotid body ablation, but delocalization is quiet in neck In one (for example, facial vein, is not shown) in arteries and veins 12 or its tributary.It further depict the optional blood in arteria carotis communis 3 Pipe angiography catheter 97, the arterio-angiography image in the region for producing carotid bifuracation 2, to allow the visualization in the region And the oriented energy of carotid body is melted for guiding from jugular vein 12.As shown, use standard angiographic skill Art inserts angiography catheter 97 in femoral artery 8 by the insertion position 9 in groin, then advance through abdominal aorta 7, The arch of aorta 6 simultaneously enters left common carotid artery 3.The technical staff in intravascular intervention techniques field will be understood that, it means that arteria carotis Means beyond angiography can be used for being melted through vein oriented energy for guiding carotid body.For example, can individually or group Close and be imaged using the external supersonic of neck, and intravascular ultrasound, computer tomography angiography and other known Mode.It is also understood that although Fig. 1 shows that left carotid artery body melts, can be carried out in embodiments herein Right carotid artery melts or bilateral carotid arteries ablation.

Ultrasonic examination can help to instruct percutaneous and endovascular surgeries.Can be from skin surface (such as neck), from vascular Internal system, via imaging transducer in ablation catheter or thereon inside vascular system, or from the day of such as esophagus Right cavity carries out ultrasonography.

Oriented energy device used herein refers to there is the elongated dress for the energy emitter for being configured as emitted energy Put, and wherein the device is configured to the energy of orientation being transported to destination organization.In some embodiments, the device includes Therapeutic ultrasound transducer (also referred herein as energy emitter), it can be located in the distal region of device.In application method In, the device can be positioned in patient body, close to the carotid body or related neural of patient.Then activation therapeutic ultrasound Transducer, and the acoustic energy for being capable of heating ablation tissue is transported to destination organization, ablation targets tissue such as carotid body.Generally It is expected that oriented energy is penetrated in a manner of causing the volume-heated to the tissue of a volume in the direction that energy is launched Tissue.It is expected that with the distance increase away from emitter, oriented energy is deposited, and is converted into heat and metaplasia, and thereby subtracted It is weak.Due to the decay in tissue, border or distance that oriented energy will not be penetrated in a manner of biologically significant be present.When Volume heating (the volumic of the destination organization occurred during using therapeutic ultrasound ablation energy as described herein Heating), different from the conductive heater of tissue, the conduction heating of tissue needs to heat from contact point, through group between Knit and reach destination organization.However, there may be a certain degree of conduction heating with volume heating.However, use directional energy Amount, intended volume heating are the heated Main Means of destination organization.In addition, oriented energy such as therapeutic ultrasound energy is not required to Effectively to be conveyed with the close contact of target.Ultrasound can be by blood born, than the absorption in carotid body region Low about ten times, such as allow energy to be conveyed in the case where not being in close contact vascular wall (such as arteria carotis or jugular vein), or The distance from transmitter to the wall is not thought better of even.When vascular wall is irregular or easily damaged, this is probably important.

Ultrasonic acoustic energy is arranged on surpassing in elongated devices (such as conduit) or around it by ultrasonic transducer by being electrically excited Pinger produces.In some embodiments, ultrasonic transducer can be energized, with about 10MHz to about 30MHz Scope in from transducer face produce orientation acoustic energy.Transducer can be for example in the range of about 10% to about 100% Energized under dutycycle.The much higher energy density for navigating to small volume of focus can be had by focusing on ultrasound, but will generally be used Shorter time for exposure or dutycycle.In the case where heating tissue, temperature of the transducer generally in tissue is made is increased to greatly It is energized under conditions of about 45 degrees Celsius of tissue temperature.In this case, cooling elongated devices are located in therein Cavity surface is probably desired, to reduce the risk of damage.

This document describes the embodiment of the ultrasonic transducer for being placed on patient's body for supersonic melting carotid body. This ultrasonic transducer can be used in any carotid body ultrasonic ablation device described herein.For example, herein is any super Sonic transducer can be merged in carotid body ablation catheter, and the conduit has deployable or expansible structure (for example, ball Capsule, cage, basket, net or coil), to position, be aligned and keep transducer steady in blood vessel such as external carotid artery or jugular vein Positioning is put.

Fig. 3 A show the exemplary of ultrasonic transducer.As shown in Figure 3A, ultrasonic transducer can be gathered with right and wrong Jiao, planar unit mode part transducer, two main surface is substantially parallel to one another.Transducer hole shape can be rectangle, or Alternately it can be circular, ellipse or be designed to be adapted to appointing for ablating device (for example, conduit or detector (probe)) What other shapes.The width of transducer hole can by ablating device size (for example, diameter) limit, such as to 2F, 3F, 4F, 5F、6F、7F、8F、9F、10F、11F.By increasing the length of device distal component, the length of transducer hole can be more than its width Degree.It is proposed that 4 to 6mm length surface area and guiding-tube bend and is navigated through between the ability of anatomical structure as needed for Reasonable tradeoff.In order to ensure the convergence of the beam of ultrasound energy of transmitting, the substantially flat transducer face of rectangle can be made It is slightly convex.

It it is generally desirable to emitter facet surface placing transducer towards target.Such as by using by sensing internal carotid The low intensity ultrasound Doppler guiding of interior blood flow, the distal component of the ultrasound transducer element comprising ablating device can be drawn Lead the appropriate location in such as external carotid artery.Along supersonic beam axle, it is more impulse wave can be adjusted in length and position The sampling volume of general Le.Coverage distance energy converter planar about 2 is preferably set to along the position of the sample volume of beam axis To 15mm (for example, about 2mm to 9mm) scope.Supersonic beam can be directed at by means of Doppler to cover arteria carotis to be ablated Body.Once it is determined that transducer is correctly aligned, then high intensity continuous wave or high duty ratio (preferably greater than 30%) pulse can be used Ripple ultrasound melts carotid body and other desired object constructions.Impulse ultrasound has cools down transducer and blood by blood flow Pipe, while continue the advantages of heated further from the arteria carotis barrier film of carotid artery flow.Ultrasonic Doppler guides and supersonic melting Identical element of transducer can be used, or single element of transducer is alternatively used to perform.Alternatively, ultrasound is changed Energy device can be made up of annular array, such as used with the spider melted for high intensity and for low-intensity Doppler The two-element array of outer ring.

This paper transducer can be configured as realizing heating ablation, and wherein maximum heating region is concentrated on along supersonic beam axle In energy converter planar about 2mm to 9mm tissue.In some embodiments, transducer is configured as realizing heating ablation, wherein Maximum heating region is concentrated in energy converter planar about 5mm to 8mm tissue.As described elsewhere herein, away from transducing Ablation in the so remote tissue of device can allow selective carotid body to melt, while minimize and other non-targeted group of ablation Knit the risk of correlation.The shadow of the mechanical energy dissipative of supersonic beam during tissue is cooled down and organized by blood is heated by intravascular ultrasound Ring.The position in maximum heating region depends on transducer designs, specifically, aperture size and operating frequency, which defines companion Decay and ultrasound beam shape with distance.Generally, the ultrasonic wave of upper frequency its by organize to advance and when being absorbed Decay in shorter distance.Maximum heating zone position can be fixed with one-element transducers.Alternately, phased array can be used The transducer of technology (phased array technology), acoustic lens or geometric focusing by ultrasonic beam turn to needed for most Big heating zone position.The device can be designed to realize about 8mm³To 300mm³(for example, about 154+/- 146mm³) ablation tissue Volume.The combination of the energy of conveying, the shape of ultrasonic beam, direction and application time order may decide that the body of ablation tissue Product.It can be conveyed using energy, such as power setting and operator scheme (for example, impulse wave is to continuous application time sequencing) increase The target tissue temperature repeated with the time is heated and realizes in strong target location or region.In example embodiment, For being about 2mm with width and transducer that length is about 4mm, ultrasound procedure frequency can be selected be about 10MHz to about 30MHz (for example, 15MHz to 25MHz).In some embodiments, the frequency conveying ultrasound between about 10-25MHz.One In a little embodiments, the frequency conveying ultrasound between about 10-20MHz.In some embodiments, between about 10-15MHz Frequency conveying ultrasound.In some embodiments, the frequency conveying ultrasound between about 15-30MHz.In some embodiments In, the frequency conveying ultrasound between about 15-25MHz.In some embodiments, the frequency conveying between about 15-20MHz Ultrasound.In some embodiments, the frequency conveying ultrasound between about 20-30MHz.In some embodiments, with about 20- Frequency conveying ultrasound between 25MHz.In some embodiments, the frequency conveying ultrasound between about 25-30MHz.

Ultrasonic transducer can be operated with thickness resonance mode, i.e. operating frequency is substantially by piezoelectric transducer element Half-wavelength thickness determines.Element of transducer can by PZT-4 (Navy I) or PZT-8 (Navy III) type piezoceramic materials or Low-loss equivalent is shown under high power drive condition to be made, and can be incorporated into that in Piezoelectric anisotropy structure.It is high-strength Degree, high duty ratio, mode of operation can cause the self-heating of element of transducer and surrounding structural elements.Therefore, temperature can be used The temperature of sensor (for example, thermocouple) monitoring transducer or adjacent elements.If temperature is considered as too high, can by Dutycycle or the electrical power being output in transducer, or flushing or circulation of fluid cooling are reduced during use, and transducer is cooled down Get off.It is alternatively possible to transducer efficiency is strengthened to reduce transducer spontaneous heating by electrical impedance and acoustic impedance match.Example Such as, (inductive tuning) can be tuned by inductance to eliminate or reduce the capacitive reactance of electric transducer impedance.If transducing Device performs imaging or Doppler's sensing function, and the acoustic impedance of usually used piezoelectric (is defined as multiplying for the velocity of sound and density Product) it is far above the acoustic impedance (e.g., from about 20x) of soft tissue.Therefore, the coupling of acoustic energy and soft tissue from element of transducer is not It is preferable.The means for improving acoustic energy coupling can be in transducer face between element of transducer and tissue use in work frequently The about matching layer of quarter-wave thickness or multiple matching layers under rate.In theory, the acoustic impedance of matching layer should be close to source, piezoelectricity Element of transducer (about 30MRayl) and loaded article, the geometrical mean of soft tissue (about 1.5MRayl).It should be appreciated that raising sound The certain methods of effect may be more related to high-energy conveying, and some are more related to imaging and Doppler's sensing.

In some embodiments, can by including by acoustic impedance less than soft tissue or water acoustic impedance (about 1.5MAyal) divided by matching layer made of the material of transducer mechanical quality factor (being measured as in water between 0 and 100) is next excellent Change the validity of the therapeutic high-energy mode transducers to be worked in a continuous mode at resonant frequency or close under resonant frequency. Improve the common method that the power between water and the acoustically ceramics of hard conveys by inserting quarter-wave matching layer It is not practicable for undergoing the situation of the planar transducer of big displacement in resonance.Can be for example by by polyester, polyurethane or poly- The thin layer of imide polymer is directly bonded to the emitting surface of ceramic transducer to build thin treatment matching layer.Alternatively, Treatment matching layer can be built by polyvinylidene fluoride (PVDF), and PVDF may be used as being directly connected to treatment transducer face Image-forming component or multicomponent imaging array.PVDF is the piezopolymer for having low acoustic impedance, is highly suitable for ultrasonic imaging. Depositions of the PVDF on the emitting surface of high impedance hard treatment ceramics can help to Miniaturization Design and optimize under Therapeutic mode Power transmission, and ultrasonic imaging function is obtained in folded transducer.

Fig. 3 A show that the exemplary piezoelectric with top (or anterior) electrode 151 and bottom (or rear portion) electrode 152 changes Can device element 150.Element of transducer 150 can be by PZT-4 (Navy I) or PZT-8 (Navy III) type piezoceramic material system Into.PZT-4 and PZT-8 section bar material are referred to as that " hard PZT ", it has of a relatively high mechanical quality factor, and (e.g., from about 500 to about 1000) high intensity and high duty ratio application are especially suitable for and high-curie temperature (for example, more than 300 DEG C), and therefore.Transducer The top 151 of element and the electrode of bottom 152 can be welding, to provide reliable electrical connection to transducer face.Have The electrode of negative polarity is preferably located on the external radiation surface of transducer, towards organizational goal.It is top in this embodiment Portion's electrode 151.

Fig. 3 B show exemplary piezoelectric element of transducer 153, have size undersize on the element back side Electrode 154.The purpose of the undersize electrode of size be avoid undesirably being electrically connected to transducer housing component it is (i.e. short Road) possibility.Top (or anterior) electrode 155 can substantially cover the entire surface of element of transducer 153.

Fig. 3 C show the example being installed to element of transducer 150 in housing unit 157, wherein illustrate only for saying The partial view of bright purpose.Element of transducer 150 can be located substantially at or close to ablating device (for example, conduit or detector) Sheath axis at, to allow maximum transducer width.The backing that element of transducer 150 is rested on acoustic insulation body 159 is empty On chamber 158, O-ring or framework made of the biddability material that the acoustic insulation body is for example served as reasons soft.The purpose of insulator be by The acoustic vibration of element of transducer is kept apart with housing unit.The side of element of transducer 150 can use offer gas-tight seal Filler 164 seals.At the back side of element of transducer, backing cavity 158 can use the gaseous state of low acoustic impedance or foamed material to fill. Low acoustic impedance can be defined as speed of sound and the product of density of material.Backing cavity be hermetically sealed with environment (not shown) every From to prevent the rear-face contact of any liquid and element of transducer 150.Electrical connection can include being connected to preceding transducer electrode 162 negative pole 160, and it is connected to the positive pole 161 of rear transducer electrode 163.Electrical connection can be for example soldered or welded.

It is alternatively possible to prevent energy from being diffused up in the side in addition to target using the material with acoustic impedance. Backing can be made up of fine and close and high-sound-velocity material, the metal of the material such as reflection of the acoustic energy, such as stainless steel.Generally have Excessive place (transition) or interface between the material of dramatically different acoustic characteristic (for example, velocity of sound) are by reflection of the acoustic energy.

Fig. 3 D show the top view of transducer distal component or preceding surface.Spool chamber 165 can be provided for arriving transducing The electric wiring path of device, the path are connected to the Pulsed-Wave Doppler circuit and RF signals that can be included for melting in the near-end of device The controller in source.Identical spool chamber 165 can be used for for thermocouple wire being connected to the distal end positioned at element of transducer or device Thermocouple 166 on component.

The embodiment that Fig. 3 E show the distal portions of supersonic melting conduit, it includes being positioned at conduit sheath 167 Rectangle ultrasonic transducer 150 at axis or near it (as shown in Fig. 3 A, 3C and 3D).Conduit can be configured as passing through application Tension force controllably deflects, with actuator pulls wire in handle.Bracing wire can pass through sheath and be anchored on conduit Near distal portions.

From positioned at intravenous catheter in blood vessel supersonic melting carotid body

This disclosure is transported to one of jugular vein or its tributary including wherein ultrasound ablation conduit So that ablation energy to be directed to the embodiment of arteria carotis barrier film.Compared with through artery apparatus, may have through intravenous devices excellent Gesture, because they have relatively low cerebral embolism risk.In addition, bigger apparatus can be used for transvenous method.

Present disclosure be on one side carotid body ablation method, it includes drawing the elongated devices of such as conduit In the venous system for entering patient, the distal end of conduit is promoted to one of jugular vein or its tributary of arteria carotis near diaphragm, wherein Distal region includes the directional transmitter that can convey the high-energy ultrasonic of ablation acoustic energy, and transmitter is aligned with arteria carotis barrier film, And energy is directed in barrier film with ablation targets tissue (such as tissue in carotid body, arteria carotis barrier film, carotid body god Through).

Fig. 4 A and 4B show the exemplary through jugular vein supersonic melting conduit.As Fig. 4 A are visible, jugular vein With the close chance provided with the device ablation carotid body being located in jugular vein of arteria carotis barrier film and carotid body.Such as figure Shown in 4A and 4B, conduit 313 includes ultrasonic transmitter 230 and optional receiver.Transmitter can be in selected direction (example Such as, the unfocused ultrasonic beam of the high-energy of orientation) on transmit high energy ultrasonic.Backing 231 is reflected (for example, by for example empty Gas, foam or acoustic insulation body made of compact metal) reflectance ultrasound ripple 232 or ensure they largely be directed into it is desired Direction.Calculate or experimentally determined frequency, power, duration and aperture (its Consideration is described in detail above) are to melt Tissue in arteria carotis barrier film 205, but prevent ablation energy from penetrating and more than barrier film, such as the centre more than arteria carotis barrier film Border 233.For example, transmitter may be configured so that transmitted ablation energy can deposit to tissue from transmitter 230 In no more than about 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm or 3mm.In some embodiments, transmitter It is configured such that high-energy ablation ultrasonic wave is penetrating into soft tissue about 3mm to about 12mm, such as into soft tissue about 3mm, into soft tissue about 4mm, into soft tissue about 5mm, into soft tissue about 6mm, into soft tissue about 7mm, into soft group About 8mm is knitted, into soft tissue about 9mm, into soft tissue about 10mm, into soft tissue about 11mm, or enters soft tissue about 12mm Ablation power will be lost afterwards.The size of barrier film there may be certain variability different because of patient, and therefore in ablation The preceding visualization for obtaining barrier film, the estimation size of barrier film is obtained, and the use of transportation parameters can have based on the size of estimation Benefit.

It is expected that produce expectation about 10 to the stimulating frequency (e.g., from about 10MHz to about 20MHz) about in the range of 30MHz Effect, including enough ablation energy penetration depths and simultaneously control needed for zone of ablation.Outside internal carotid 90 and neck The cooling of blood flow in artery 91 can help to ablative heat energy or zone of ablation being limited in arteria carotis barrier film.Therefore, come from The heat distribution of ablation ultrasonic beam can be shaped additionally by the uneven heat transfer in region, and uneven heat transfer is moved by neck Heated caused by the blood flow and ultrasound of the cooling in object space (i.e. arteria carotis barrier film 205) between arteries and veins 90 and external carotid artery 91 Associated biomolecule effects.Due to the effective radiating (thermal cooling) of high blood flow and the thing followed to blood vessel, Ultrasonic energy in selected frequency range is by vascular wall and blood without significant biological action, therefore only barrier film will be by Selectivity heating.Present disclosure is ultrasonic to the conveying high intensity ablation of arteria carotis barrier film on one side, while using in neck The cooling effect of blood in artery and external carotid artery optionally only melts the method for diaphragm tissue.It is it is expected that some logical Cross scattering decay reduce after ultrasonic effect and protect the non-targeted structure behind artery.The principle can be categorized as passing through The ultrasonic beam being formed in three-dimensional vascular space forms damage using heating (thermal heating).In some embodiment party In case, the ultrasonic energy launched by the temperature of diaphragm tissue by being increased to about 45 degrees Celsius to melt diaphragm tissue, so And the tissue of exterior remains less than about 45 DEG C, therefore it is not ablated to.Ablation is the function of temperature and time, and longer ground is sudden and violent It is exposed to relatively low energy and temperature can also ablation tissue.Present disclosure is primarily upon temperature, and including lasting about 5 to about 60 The processing of second.However, the temperature being mentioned herein is not necessarily to be construed as strict limitation.

The choosing of ultrasonic therapy parameter such as power, frequency, time and mode (such as (pulsed) of pulse or continuous) Select and may insure that ablation of the ultrasonic beam to tissue will not be more deeper (for example, no more than about 9mm is deep) than away from jugular vein about 15mm.It is right 1dB/cm/MHz exemplary ultrasonic is decayed in musculature, and the depths of features for not focusing on ultrasonic penetration in tissue is decay system The inverse of number divided by frequency.For example, in 10MHz, feature penetration depth is 7.7mm, and in 20MHz, feature penetration depth For 3.8mm, it corresponds roughly to an example of target range scope in across jugular vein catheter configurations.

Fig. 4 B show the conduit 313 that (for example, via femoral vein path) introduces from below.Intravascular method hereafter can With including entering desired jugular vein through vena cave through the femoral vein in patient's groin and by conduit, such as shown in Fig. 1. Such as from other alternatives of jugular vein and jugular branch and other veins such as subclavian vein of body be also possible , and may have advantage in some clinical settings.

Acoustic beam is directed in the barrier film between two carotid artery bifurcations from jugular vein 12 and is advantageous to by the cold of arteria carotis But effect shapes damage.As shown in Figure 4 A, energy beam 232 is limited between two carotid artery bifurcations, and these branches are high CBF is protected from fire damage.Therefore, the advantages of anatomical structure in the region provides inherence, is, if acoustic beam is slightly Misalignment and somewhat wrong angle is pointed to, then it will run into internal carotid or external carotid artery, and it will be supported by cooling effect Close to the heating of tissue around anti-.The acoustic beam or the part of acoustic beam being directed between branch will be subjected to less cooling, and will Cause the ablation of tissue, it is contemplated that target organ such as carotid body 89 and associated nerve are located in the tissue (that is, in neck In artery barrier film).As a result, arteria carotis barrier film is selectively heated and heating ablation, and this is one of aspect of present disclosure.Such as Upper described, present disclosure also includes the method for optionally ablation targets tissue, by the way that high intensity ultrasonic energy is transported to In the region of anatomical structure so that blood flow will provide cooling effect and therefore promote the tissue of ablation being restricted to desired Region.In the case of the present embodiment, the tissue of ablation is comprised in arteria carotis barrier film.

By using diagnostic ultrasound such as doppler ultrasound detection vascular system such as arteria carotis communis 3, the and of internal carotid 90 External carotid artery 91 and carotid bifuracation 2, guiding and targeted ultrasound out of jugular vein can be helped to melt beam 232 to target site Such as at arteria carotis barrier film 205.This diagnostic ultrasound can be by including at least one in manipulation (for example, rotation and translation operation) Blood flow velocity, flow direction, Pulsating Flow (pulsations of flow) and rapids are detected while the conduit of individual ultrasonic transducer (turbulence) is flowed to provide the instruction of vascular system (for example, visual pattern, acoustics or electric signal).

In some embodiments, can incite somebody to action by detecting carotid bifuracation saddle 2 and relative to carotid bifuracation saddle Ultrasonic therapy energy converter (also referred herein as supersonic melting transducer or supersonic melting transmitter) run-home position is realized Translation aims at (aligned therewith in some cases).In some embodiments, ultrasonic therapy energy converter is aimed at away from bifurcated saddle Cranium end about 5 to about 15mm, the cranium end about 10 away from bifurcated saddle is to about 15mm in some embodiments, at some The cranium end about 10 of embodiment middle-range bifurcated saddle is to about 12mm, and the cranium in some embodiments away from bifurcated saddle End about 5 to about 10mm.Carotid bifuracation saddle can represent arteria carotis communis from the position of the length along jugular vein 12 The opening position that the strong blood flow velocity signal of one of 3 is separated in two arteries (internal carotid 90 and external carotid artery 91) suddenly is detected Measure.By promoting or retraction conduit, supersonic melting beam can aim at the about 5mm to about 15mm above the horizontal plane of bifurcated saddle Position.By acoustic beam aim at bifurcated saddle tail end about 5 to about 15mm position by acoustic beam aim at enter arteria carotis barrier film so as to In the ablation of carotid body.

In some embodiments, the method for ablation includes one or two in detection internal carotid and external carotid artery. They can be detected by rotational diagnostic transducer, and diagnostic transducer can exist together with conduit or sacculus, or in conduit Or in sacculus.Treating transducer then can be relative to internal carotid and external carotid artery run-home position.In some embodiment party In case, external carotid artery and internal carotid are detected, and treat transducer and rotatably substantially aim in internal carotid and external carotid artery Between.So that relative to the orientation of two kinds of arteries, ultrasonic therapy energy converter is intended to melt diaphragm tissue and thus melts arteria carotis Body.In other embodiments, aiming sound is aided in by such as other of MRI, CTA or fluoroscopic examination visualization technique Beam.Ultrasonic transducer optionally can also convey and receive how general available for arteria carotis imaging, doppler imaging or pulse Strangle the low power ultrasound of imaging.This document describes the example of the transducer constructed by this respect.Operation to control energy conveying The Doppler signal of person or computer feedback is not necessarily image.It can be for example curve, numeral, voice signal, LED strip or The instruction of the color or intensity of indicator lamp.

Optionally or additionally, ultrasonic imaging can be applied and be used for from the outer transducer being placed on patient's skin of neck Guiding treatment.The ultrasonic imaging that outside applies can be incorporated to biplane imaging and Doppler flows Enhanced Imaging.It is alternatively possible to Other ultrasonic transmitter and receiver are incorporated in catheter design.

Optionally or additionally, single or multiple ultrasonic transducers can be positioned in the distal part through jugular vein conduit, So that the ultrasonic reverberation between the outside of neck surface and ultrasonic transducer is sensed with electrical impedance or by ultrasonic imaging, so as to Allow conduit to be aligned relative to the lateral mark of neck, effectively point to treatment transducer towards the interior side of neck inner septum To.Laterally it is reflected into catheter-based ultrasound transducer and acoustics guiding is provided, when catheter-based ultrasound imaging transducer becomes and external collar surface Substantially copline (this can be overlapped with relative to the expectation rotation position of carotid bifuracation) when, its effect maximize.It is optional Ground, can be by the way that the reecho device of substantially flat or active low power ultrasound transducer be placed on the surface of neck come real Now similar is laterally guided.

In this paper some embodiments, ablation catheter can from groin, under clavicle, from brachial vein or use with The slightly similar method of those methods for placing for biopsy or central corridor conduit is traveled into quiet in neck by Direct perforantes Arteries and veins.In some cases, facial vein or from other veins of jugular vein branch can provide closer to arteria carotis barrier film with Just the placement of the energy delivery element of conduit.Therefore, it is merely illustrative for the jugular vein of the venous locations of conduit.

As described in methods herein, conduit can move up and down in jugular vein, until being clearly detected directly over it Arteria carotis communis bifurcated and arteria carotis barrier film.If using external ultrasound, by adding echo coating conduit can be made to become ultrasound It can be seen that.This can be confirmed by Doppler pulse rate signal or ultrasonic imaging.There is the big of high pulsatile flow amount at two Between blood vessel, it be able to should easily detect to indicate the space of arteria carotis barrier film.It can select in the pre- of 3 to 10mm (such as 3 to 5mm) The pulse Doppler of depth is selected to avoid the interference to venous blood flow.

In some embodiments, the conduit being positioned in jugular vein, which can enclose, to be rotated about the axis thereof, until melting transducing Device treats the hole face of transducer to the arteria carotis barrier film in the inwardly directed gap between outer arteries.Alternatively, it is fixed to have Can be in conduit internal rotation to the transducer of transmitter.It is placed on if Doppler transmitter and receiver are located in jugular vein In the distal portions of conduit, then some advantages can be realized.Low energy Doppler acoustic beam can melt acoustic beam towards with high-energy Identical direction.Then Doppler signal can be used to target and guides ablation beam to enter barrier film.Barrier film can be located at two The lowest point of low-speed region between peak or high-speed region.It is alternatively possible to several Doppler's transducers are incorporated into remote tip In, acoustic beam is silently aimed at the angled place in hole face direction with high energy beam, will pass through the high speed of two arteria carotis Flow to detect two arteria carotis.Vein can be expanded, and catheter tip being maneuvered to suitable position so that high Energy emitter aims at the centre for representing the gap between internal carotid and the two strong Doppler signal of external carotid artery.Computer Algorithm can help or automate this aiming.

During ablation, ultrasonic energy emissions device may heating, and may need to cool down.Conduit can be configured as by Transducer is positioned in jugular vein so that it will not contact jugular wall, while convey high-energy for ablation purpose.Example Such as, as illustrated in figures 4 a and 4b, conduit can include the diaphragm of such as sacculus 145.Sacculus 145 is by transducer 146 and vascular wall 147 separate, while provide pipe for the blood in the cooling of energy beam and transducer, vein 12 and the tissue of jugular wall Road.Sacculus 145 can be made up of thin polymer film, and it can be submissive or non-compliant, but can bear some pressures Power, there is provided conduct ultrasound is without significant decay, reflection with the rigid contact of vascular wall and in selected frequency range Or heating.Sacculus can be filled with circulation of fluid 148, such as sterilized water or salt solution, and it is biocompatibility and passed well Ultrasonic wave is led without absorbing significant energy.Fluid can be cooled down by outside, by the recycling of external pump (not shown) through leading Pipe sheath, or can only with it is relatively little of, be enough fluid and submergence transmitter in a fluid keeping desired low temperature Amount inject and be discharged into blood flow.

Diaphragm can surround the distal end of conduit completely, and sacculus is formed around ultrasonic transducer, or such as Fig. 9 A and 9B institutes Show, diaphragm 250 can partly surround selected ultrasonic transducer 251.Diaphragm can surround therapeutic transducer shape As the shape of convex, spill or Fresnel acoustic lens, and liquid coolant 252 is filled with, such as with basic with blood The Fluorinert of different acoustic characteristics.Ultrasonic beam for predetermined focusing or can be defocused by protectiveness film forming lens Pattern, to obtain the sensitivity of selection area in doppler imaging or the therapeutic dose of conveying to be obtained in ablation areas. Alternatively, the transducer with the expansible diaphragm of predefined thin-walled can form directional transmitter, and directional transmitter can quilt Manipulation can be targeted to the directed beams of different depth to be formed.The target depth of Doppler transmitter and receiver can be configured as So that ultrasonic beam shaping is realized when the substantially different anatomical structure in jugular vein and arteria carotis complex and is focused on The advantages of.

Conduit can be by being placed in jugular vein and manipulating lens interior Fluid pressure come real by depth of ablation control It is existing, so that with predetermined repeatable shape propagation diaphragm, the shape produces acoustics convergence to ultrasonic beam or divergent lens is imitated Answer, and ultrasonic beam is preferentially targeted to the specific objective depth in the bifurcated of arteria carotis with arteria carotis barrier film.For example, such as Fig. 9 A It is shown, film 250 is extended with cooling agent 252, produces the lens shape for focusing on ultrasonic beam 253 on target area 254.Phase Than under, as shown in Figure 9 B, it can extend film 250 with the cooling agent 252 of different pressures, will be super to change lens shape Beam of sound 253 is focused on the target area of different distance.Expandable membrane can be formed by various submissive polymeric materials, example Such as Kraton (styrene blend), polyethylene, polypropylene, Pebax or Latex.Alternatively, expandable membrane can be used for relatively Conduit is controlled in intrajugular positioning in the distance to arteria carotis complex.

As shown in Figure 10, the distal end of an embodiment of carotid body ablation catheter is included positioned at conduit sheath 258 The ultrasonic transducer 255 and PVDF imaging arrays 256 of proximate distal ends.The acoustic insulation body 257 of such as stainless steel can be determined Position is on the back side of transducer 255, to ensure to be imaged or melt the side that acoustic beam is guided in the preceding surface for being orthogonal to transducer 255 To on 259.The cavity that expandable membrane 250 is surrounded before transducer.The liquid of such as cooling agent can be injected into the cavity of film, The intended shape of ultrasonic beam can be focused on or guide by being expanded into film 250 through expansion chamber or pipe 260.

In an alternate embodiment, including supersonic melting transducer and expandable membrane (that in such as Fig. 9 A, 9B or 10 Any conduit a bit) can also include being attached to conduit any diagnostic transducer as described herein (such as Fig. 5 A-B, 6A-B, Those in 7A-C), it can be used for help and positions ablation transducer and be aligned with one or more vessel landmarks, such as Carotid bifuracation, internal carotid, external carotid artery or its combination, will melt ultrasonic beam vector tissue volume, such as neck Position in artery barrier film or arteria carotis barrier film.

Ablation catheter can include supersonic melting transducer and expandable membrane, such as the film 250 shown in Fig. 9 A, 9B or 10, Wherein supersonic melting transducer can be used for diagnostic ultrasound such as Doppler.These conduits can be positioned in external carotid artery simultaneously And rotated while diagnostic signal is assessed, this can be used for the blood vessel for finding such as internal carotid or jugular vein.In fluorescope With the help of imaging, transducer can be placed on the desired distance in external carotid artery middle-range carotid bifuracation cranium side, and e.g., from about 5 to about 15mm, or about 5 to about at 10mm.For example, conduit can have and be disposed close to the desired distance of transducer (e.g., from about 5mm be extremely About 15mm, or about 5mm to about 10mm) place radiopaque label；Contrast agent transport can be sent to arteria carotis communis (for example, from Delivery sheath), the radiography images of the distal portions of arteria carotis and conduit can be obtained, and radiopaque label can To be aligned with carotid bifuracation.When diagnostic transducer is aimed in internal carotid or substantially in the center of internal carotid and transducer position When at away from carotid bifuracation cranium side desired distance, it is contemplated that transducer is aimed at through arteria carotis barrier film.Melt ultrasonic beam It may be directed in the destination organization in arteria carotis barrier film.Alternatively, conduit can also be included close to the deflectable of transducer Partly (for example, about 5mm and about 30mm between) near transducer, deflectionable part can be used for guiding ultrasonic beam relative to The angle of external carotid artery, this can be used for the tune of for example narrow or wide bifurcation angle of the geometry to various arteria carotis vascular systems It is whole.Optionally, conduit can also include the extensible structure away from transducer on conduit, such as sacculus, cage, net or spiral shell Rotation, it can be used for engagement and distal portions of the stabilizing catheter in external carotid artery.Extensible structure can be launched into suitable for connecing The size of external carotid artery is closed, such as with about 4 to about 6mm diameter.Extensible structure can be retracted so that it can be assembled In delivery sheath, the delivery sheath such as diameter with less than about 3mm (for example, between about 2mm and about 2.4mm).

This disclosure also includes the methods, devices and systems for ablation targets position：By the way that ablation needle is determined Position inserts a needle into through vein and entered around the blood vessel comprising target site in the tube chamber of the vein adjacent with target site In space, perivascular space is delivered into by agent is melted by using pin, and pin is withdrawn into vein from perivascular space In.Compared with through artery method, arteria carotis body ablation procedure through vein method positioner by there may be potential benefit. For example, compared with arteria carotis, jugular vein has thinner wall, and the wall can be easier to pass through ablation needle；Jugular vein is to expand Opening and flexible, and can be by constructing change from internal blood vessel or outside force to realize, this is advantageously possible for promoting The placement of conduit or close to target ablation position；Jugular vein does not have atherosclerosis or an arteriosclerosis disease, and blood is from brain Portion flows out, and eliminates the risk for causing cerebral embolism (this is probably a problem of arteria carotis program)；Can be from through jugular vein approach Side is close to arteria carotis spacer film；Compared with arteria carotis, due to the compressibility of vein blood vessel, through vein (for example, neck is quiet Arteries and veins, facial vein) wall is threaded a needle or conduit, there is the risk of lower complication such as hemotoncus；Reduced with the flow of internal carotid Compare, the CBF in jugular vein is likely to reduced the risk with flowing of the smaller limitation to brain.

Include the distance between AA- arteria carotis (for example, in the range of about 3 to 5mm) with exemplary feature size, The distance between BB- jugular veins and arteria carotis diaphragm center (for example, in the range of about 5 to 15mm), in CC- arteria carotis barrier films The generation of the distance between the important non-targeted structure on the inside of the heart and arteria carotis barrier film (for example, in the range of about 5 to 10mm) The exemplary anatomical structure of table figure 2 illustrates.Embodiments described here can be configured as safely and effectively to To enclose vein defeated to destination organization such as carotid body or arteria carotis barrier film from such as jugular vein or facial vein near for ablation energy Send.

Supersonic melting conduit with imaging transducer

In some embodiments, carotid body supersonic melting conduit includes at least one diagnostic ultrasound transducer and ultrasound Transducer is treated, wherein these transducers are positioned relative to each other on conduit so that when diagnostic ultrasound transducer and vascular system During system mark alignment, treatment transducer is aligned with target ablation position (such as arteria carotis barrier film).Arteria carotis blood used herein Pipe mark includes internal carotid, external carotid artery, carotid bifuracation and arteria carotis communis.The configuration allows diagnostic transducer and mark Alignment, with the alignment of instruction treatment transducer and destination organization.In some embodiments, when diagnostic transducer is aligned with mark When, treatment transducer by appropriate location to be activated without extra movement with successfully ablation targets tissue. In Fig. 5 A, 5B, 6A and 6B, diagnostic ultrasound transducer 125 can be located at the preset distance of neighbouring treatment ultrasonic transducer on conduit, E.g., from about 5 to about 15mm so that when diagnostic transducer 125 is aligned with mark 2 (being in this case carotid bifuracation), control Treat transducer 126 apart from bifurcated preset distance 127 (e.g., from about 5 to about 15mm), and with the ablation targets 128 in arteria carotis barrier film Alignment.Diagnostic transducer 125 can provide material of the signal as the ultrasonic wave in the capture region 129 to Reflection Transducer The feedback of (such as tissue, blood flow).Can be by rotation or translational movement conduit or by electrically or mechanically manipulating transducer To create scanning motion with search sign such as arteria carotis communis or carotid bifuracation.The feedback for carrying out self diagnosis converter 125 can be with It is processed into image 130, sound, waveform or electric signal as shown in Figure 6B.

Fig. 7 A-C show the exemplary ablation catheter including the first and second diagnostic ultrasound transducers.As shown in Figure 7 A, Conduit may also include to be configured as detecting internal carotid 90 and the first diagnostic ultrasound transducer 132 of external carotid artery 91 and second and examine Disconnected ultrasonic transducer 133.Transducer can be configured as capturing image 134, acoustical signal or electric signal as shown in figures 7 b and 7 c. Fig. 7 B and 7C show the cross section of two arteries.Second opinion ultrasonic transducer 133 is positioned on conduit, thus its aim at Treat the identical direction of transducer 137.When as shown in Figure 7 B, conduit rotate to wherein second opinion transducer in internal carotid and During the position 136 at the center between external carotid artery, and as seen in figure 7 c, the first diagnostic transducer 132 is aimed in arteria carotis point When pitching 2, in the barrier film at ultrasonic therapy energy converter 137 and the center substantially between internal carotid and external carotid artery and higher than point The target location 128 of fork preset distance is aligned, the preset distance e.g., from about 5 to about 15mm, and about 5 to about 10mm, about 8 to about 10mm, or about 10mm to about 15mm.

Fig. 8 A-D show that the exemplary ablation with three diagnostic ultrasound transducers and a treatment ultrasonic transducer is led Pipe.As shown in Fig. 8 A-D, conduit includes being arranged on the first diagnostic transducer 140 being aligned with carotid bifuracation 2 on conduit, set With the second opinion transducer 141 being aligned with internal carotid 90 and the 3rd diagnosis transducing being aligned with external carotid artery 91 on conduit Device 142.Conduit also includes ultrasonic therapy energy converter 143, and it is positioned on conduit with when diagnosis relative to three diagnostic transducers When transducer is aligned, ablation beam is aimed between internal carotid and external carotid artery and away from carotid bifuracation cranium side preset distance, Such as about 5 to about 15mm, about 5 to about 10mm, about 8 to about 10mm or about 10 to about 15mm target site.Or one or More diagnostic transducers can be moveable relative to conduit sheath.For example, the He of diagnostic transducer 141 shown in Fig. 8 A 142 can mechanically move (for example, utilizing transmission mechanism) to adjust the angle between two transducers, while will treat transducing Device 143 is maintained at the center between two mobile diagnostic transducers.This can allow alignment to adapt to different barrier film width. In use, all conduits shown in Fig. 4 A-8D and method produce the damage being substantially contained within arteria carotis barrier film, and from And avoid non-target tissues.In addition, the combination of venous blood flow cooling and the selection of ultrasonic therapy scheme can help to be cooled in operation The vein and emitter of period possible heating, while strengthen the Ultrasonic Heating of arteria carotis barrier film.

It is configured to receive the supersonic melting conduit of intravascular ultrasound imaging conduit

Catheter in blood vessel for carotid body ablation can be configured with therapeutic ultrasound ablation targets tissue With in order to target purpose image tissue.Conduit can include supersonic melting transducer and (also referred to as treat transducer or therapeutic change Energy device), it is configured and is adjusted to receive intravascular ultrasound imaging conduit, and intravascular ultrasound imaging conduit is suitable to according to by being imaged The sighted direction of image recognition treatment transducer caused by conduit, and suitable for energy is directed to by being imaged from treatment transducer The target of transducer identification.

In the market has many intravascular ultrasound (IVUS) conduits being used for from patient's body imaging.For example, VolcanoPV.035 is used to be imaged endovascular lesion vesselses；Boston Scientific Ultra ICE^TMWith Imaging during intravascular cardiology program.Such IVUS imaging catheters can be configured as creating regarding based on ultrasound Frequently, it is illustrated in the cross-sectional slices of the tissue of about 50-60mm radiuses around the imaging transducer on the distal region of conduit.From IVUS ducted propagations and receive ultrasonic signal be controlled and handle by the console of patient-external, and can produce and Display image is to help user to identify other objects in tissue or the visual field.Other processing can help to identify such as blood flow, The feature of presence or the tissue differentiation of patch.Existing IVUS imaging catheters can have e.g., from about 8 to 10F (for example, 8.2F, Diameter 9F).In some embodiments of ablation catheter, can by existing IVUS imaging catheters or with it is as known in the art In the IVUS imaging catheters insertion carotid body supersonic melting conduit of similar customization, to help to identify target ablation position (example Such as carotid body, arteria carotis barrier film, carotid body nerve), and identification target ablation position is relative to the position for the treatment of transducer Or its sighted direction.

Ablation transducer before imaging transducer

As shown in figure 11, in order to which an embodiment of the supersonic melting conduit 305 that ultrasonic imaging adjusts and configures configures There is the ablation transducer 300 before imaging catheter chamber 301.In this case, position refers to, and above, can be determined Justice is towards the direction 302 that supersonic melting energy is transmitted from the side of ablation transducer or conduit run-home.Can will be existing Ultrasound imaging catheter (for example, IVUS conduits) 303 be inserted into imaging catheter chamber with by one or more imaging transducers 304 away from ablation transducer positioning, and wherein imaging catheter chamber is after ablation transducer.Ablation catheter 305 can have about The diameter of (e.g., from about 12F) and conveyed in the range of 11FR to 13FR by deflectable sheath.For example, compatible sheath can be 12F compatibilities, there is about 16F external diameter, can at least one direction deflect and make together with expander (dilator) With.Ablation catheter can include supersonic melting transducer 300, such as ablation transducer as described herein, such as melt transducer Can be substantially flat, width is about 2mm, and length is about 6mm.Transducer can be configured as with about 15MHz to about 25MHz Frequency (for example, about 20MHz) resonance in scope.Ablation transducer can be installed on back lining materials 306, back lining materials 306 Ultrasonic wave is reflected or shielded, therefore ablation energy is directed only to desired conveying direction.Back lining materials can be by herein to similar Embodiment description is made, such as by the dense material or air of such as stainless steel or the epoxy resin filled with air microballoon Sorptive material be made.As shown, imaging catheter chamber can pass through back lining materials, or alternatively, if back lining materials Thin and be installed to manifold part, then imaging catheter chamber can pass through manifold part.Imaging catheter chamber 301 can be led through ablation The sheath 307 of pipe reaches the proximal end region of conduit, and sheath 307 can be such as Pebax squeeze polymer.Such as IVUS is imaged The ultrasound imaging catheter of conduit can be conveyed by imaging catheter chamber, and one or more imaging transducers 304 are positioned at In anechoic room 308 away from ablation transducer.For example, one or more imaging transducers can be with about 0mm to 5mm (examples Such as from about 2mm, about 1mm, about .5mm) imaging placed to transducer distance 309 is melted.Imaging plane is aligned to substantially by the configuration Parallel to the conveying direction of ablation energy, and can be used for conveying ablation energy at the same time or during continuous imaging, without Mobile imaging transducer or ablation transducer.Anechoic room 308 can be the space in echoless housing 312, and it allows to be imaged Or ablation ultrasonic wave passes through without producing notable echo.Echoless housing can be made up of the thin polymer of such as nylon, and It can also be visually transparent or semitransparent, to allow the property of user's observation anechoic room for example to be positioned to as transducing Device ensures that cooling agent correctly flows or removes bubble removing.Anechoic room can be sealed airtightly to accommodate the cooling agent of flowing. In this embodiment, cooling agent can be conveyed by cooling agent Delivery lumen 314, circulate changed with cooling down ablation in the chamber Energy device 300 simultaneously leaves the room along IVUS chambers 301.Ablation catheter can also include aiming artifact component (aiming as shown Artifact) 310, it can be positioned at the contra of the conveying behind imaging catheter inner chamber 301 or in instruction ablation energy To position.For example, it can be the hypotube (hypotube) for including air and being sealed at both ends to aim at artifact component, either The differentiable alternate design of ultrasonic wave such as the embodiment described herein.As shown in figure 11, aiming at artifact component can support Remote pointed member 311, remote pointed member 311 can for example be made up and adhere to aim at artifact component of polymer or metal Or the half spherical pieces of echoless housing 312.Remote pointed member can work as to be pressed against on vascular wall and allow to be inserted through sheath Wound is prevented during pipe.User can by obtain based on ultrasound video and understanding of ablation energy will be transported to it is close The ablation catheter for including imaging catheter is placed in the case of the preset distance of imaging plane, and the conduit is placed on for example in mesh Mark in jugular vein or the facial vein near carotid body.For example, ablation energy can be being begun approximately even with close to imaging plane Imaging conveys in the range of starting to ablation transducer distance 309, and height is about to melt the height 313 of transducer.Example Such as, if imaging to the distance of ablation transducer is 0.5mm, and it is 6mm to melt transducer height, then it is appreciated that ablation Energy is by 0.5 near imaging plane between 6.5mm and in the direction (for example, opposite direction) relative with aiming at artifact Conveying.Conduit can include electric conductor 315, with convey electrical current to ablation transducer or conveying from sensor such as temperature or The signal of pressure sensor.

Alternatively, similar configuration can include the imaging transducer or transducer of the part manufacture as ablation catheter Group, it is inserted into not as single device in the imaging catheter tube chamber of ablation catheter.

In an alternate embodiment, conduit can be configured as determining the imaging transducer of IVUS conduits close to ablation transducer Position.

With the embodiment of ablation catheter that imaging catheter is used together

It is configured to receive the ablation catheter of ultrasound imaging catheter (for example, IVUS conduits) can have such as Figure 12 A to 12F institutes The distal component 510 shown.Distal component may be coupled to the elongated tubular 511 as conduit sheath, such as the Pebax pipes of extruding. Distal component includes being connected to the manifold part 512 of sheath, the ablation transducer 513 for being installed to manifold part, limit chamber 515 And be connected to the echoless housing 514 of manifold, fiducial marker 516 (its be oriented to provide to melt transducer aiming side Instruction to 517) and radiopaque sophisticated 518.

Figure 12 E show the cross section of the conduit sheath of the embodiment.Extruded tube (for example, Pebax extrusions) 520 wraps The intensity containing increase simultaneously improves line braid 521 and the inner chamber of torsion capacity (torqueability).Line braid can be for example total to Extrude or be laminated to extruded tube.Two PTFE linings are inserted into the inner chamber of extrusion 520 to form two independent inner chambers. Alternatively, Pebax extrusions can be extruded as carrying two or more inner chambers.First PTFE linings 523, which define, to be exclusively used in Accommodate line 525 and convey the inner chamber 542 of cooling agent.Cooling agent for cooling down ablation transducer passes through the defeated of the inner chamber comprising line The additional benefits of cooling line can be had by sending.Line can be that high frequency electric for example is sent into ablation transducer from console, and will Temperature sensor (for example, thermocouple) with melting transducer thermal communication is connected to the conductor of console.In the figure, lead for three Line includes the constantan line and copper cash for producing the T-shaped thermocouple for being welded to ablation transducer, and conveys electrical current to the copper of transducer Line.A piece copper cash can complete Thermocouple Circuit and the conventional conductor in ablation energy loop.Can be at container (such as bag, bottle) The middle proximal end region that the coolant fluid of such as sterilized water or salt solution is provided, and ablation catheter is pumped into by peristaltic pump through pipeline On coolant entrance port, the coolant entrance port is in fluid communication with the first lining or fluid conveyor chamber 542.It will can press Power relief valve (not shown) is positioned to consistent with coolant entrance pipeline, if blocked unintentionally along the somewhere of coolant channel Prevent cooling agent from flowing, then discharge cooling agent.When the pressure in pipeline is, for example, about 30psi, pressure-reducing valve can be opened.Optionally Ground, pressure sensor can be incorporated into conduit or pipeline group to monitor coolant pressure and send signal to console to adjust Section stops cooling agent flowing or provides warning.2nd PTFE linings 524, which limit, to be exclusively used in conveying the of ultrasound imaging catheter 526 Two chambers 543 and coolant outlet.Second chamber can have shape and the diameter for being enough to allow imaging catheter 526 and cooling agent to pass through (for example, as shown) (it can be e.g., from about 8FR to 10FR (e.g., from about 8.5FR to 9FR)), while make the resistance of coolant flow Power is minimum.Alternatively, IVUS chambers can be ellipse, have the minor diameter for being enough to slidably engage IVUS conduits.Alternatively, Conduit sheath can include single cooling agent and return to inner chamber.In the proximal end of conduit sheath, imaging catheter can pass through hemostasis Valve enters the second chamber, and to prevent cooling agent from being leaked from inner chamber, and coolant outlet port can connect with the second chamber, will be cold But agent is discharged into draining container from conduit or returns it to cooling agent supply container.Sheath can have in about 11FR to 14FR Diameter in the range of (e.g., from about 12.5FR) and it is enough the length that destination organization is reached from vascular system introduce region.For example, It is configured to be introduced into the femoral vein of patient and is transported to close to the right internal jugular vein of arteria carotis barrier film or leading for left jugular vein Pipe can have the length in the range of about 90cm to 130cm (for example, about 110cm).

As shown in Figure 12 C and 12D, the first and second inner chamber linings 523 and 524 are extended to from extruded tube and manifold part 512 engage.528 ablations that are exclusively used in accommodating that line 525 and cooling agent conveyor chamber 542 are transported to manifold part by the first lining are changed A part for energy device 513, including wire management frame 527, the recessed housing 528 for installing ablation transducer assemblies, solder flux release Hole 529 and protection ridge 530.Second lining 524 and the IVUS inner chambers 531 of manifold part and the cooling agent return slot of manifold part 532 connections.The IVUS inner chambers 531 of manifold part can be passed through simultaneously by being carried through the IVUS conduits of the inner chamber 543 of the second lining 524 Enter to enter the room 515.Cooling agent in room can be left by inner chamber 531 or cooling agent return slot 532 and pass through the second lining 524 Inner chamber 543, to be removed in the proximal end region of conduit from conduit.

Manifold part 512 is connected to conduit sheath 511 and is configured as supersonic melting transducer 513 being maintained at relative In the correct position of imaging transducer 533, and guide the flowing for the coolant fluid for stopping ablation transducer overheat.With disappearing Melt transducer vibrations and produce heat.Cooling agent is by melting transducer removal heat and keeping the temperature at predetermined maximum (e.g., from about 90 DEG C) below.Melt the too high damage or right that may cause the miscellaneous part to transducer or conduit of transducer temperature The uncontrolled heat transfer of blood, blood vessel or its hetero-organization.Temperature sensor can be with monitoring transducer temperature, to ensure to cool down Liquid proper flow.If temperature is increased to more than predetermined maximum, console can stop ablation by sending error message The conveying of energy adjusts the conveying of ablation energy to respond.

As shown in Figure 12 B, shown in the decomposition diagram of manifold part 512 and ablation transducer assemblies, line 525 can be soldered to Transducer 513.For example, two wires of high frequency electric circuit can be soldered to the opposite side of transducer, and can be by constantan Line is welded to the inside side of transducer, to create thermocouple with one of copper cash.Melting transducer can be for example with cyano group third Olefin(e) acid ester 535 is adhered on transducer backing 534, and backing for example can adhere to manifold group with cyanoacrylate 536 The ablation transducer housing of part.UV adhesives 537 can be applied to the edges of transducer assemblies further to strengthen itself and manifold The engagement of part.Once transducer assemblies are adhered into manifold part to load welding point, then solder flux release aperture 529 is received prominent The welding point gone out, and for example can be filled with UV adhesives 538, produce and be electrically insulated and mechanically strengthen welding point. Protection ridge 530 defines flows through ablation transducer to the passage of echo imaging chamber 515 for cooling agent, and keeps melting transducing Space between device and echoless shell layer 539.If conduit is pressed against the inwall of blood vessel, such as can be turned to by deflection defeated Sheath is sent, then protects ridge by preventing the soft thin layer of echoless housing from collapsing to keep space.Melting transducer can be Flat, Rectangular piezoelectric transducer (for example, about 0.004 " is thick, 2mm is wide, 6mm length).The alternate embodiment of ablation transducer exists It is illustrated herein, such as the transducer or transducer array of bending.It can be about 0.008 " by thickness to melt transducer backing Stainless steel is made.The backing design of replacement illustrates herein, such as the asphalt mixtures modified by epoxy resin filled with the glass microsphere filled with air Fat.Thickness with melting the consistent wavelength of transducer can be had by melting the adhesive between transducer and backing, and can be with It is consistent thickness, to allow repeatable transducer assemblies performance, such as the uncoupling of transducer and backing.For example, for Transducer with the resonant frequency in the range of about 20MHz to 21MHz, the space between transducer and backing can be greater than about 0.0013 " (e.g., from about 0.002 ").The space can be filled with adhesive.In an alternate embodiment, it is lower than backing density Material (such as polyimides) thin layer can be placed between ablation transducer and backing, with the interval being consistent, to ensure The vibration of ablation transducer will not significantly be contained by back lining materials.

In an alternate embodiment, manifold part can be configured as producing cooling agent on ablation transducer and around it Turbulent flow.For example, manifold can have the feature similar to the manifold part 512 shown in Figure 12 B, but it can also cooled down In agent flow region, such as include ridge or raised (not shown) on the side of Protect edge information 530, or the sidepiece in Protect edge information Including inner chamber (not shown), to promote cooling agent more to be flowed in the lateral side regions of ablation transducer.

Define gas-tight seal room echoless housing parts shown in Figure 12 A, and be configured as allowing ultrasonic wave with Minimum interference passes through it.Echoless housing can include multiple layers, such as internal layer 540 can have about 0.005 " thickness Nylon extrudate, this can provide enough intensity for distal component.Internal layer can adhere to the frame 541 of manifold part.Second Outer layer 539 can be such as thin PET or nylon sleeve of the thickness in the range of about 0.00025 " to 0.0008 ".Including by Buddhist nun In the embodiment of internal layer made of dragon and outer layer, these layers can be melted together, this can with the air between eliminating layer or To the needs of adhesive.Include PET or LDPE available for the first layer of echoless housing or the other materials of the second layer or have Compared with other biocompatible materialses of low acoustic impedance.As illustrated in fig. 12, outer layer extends on manifold part and glued with adhesive Close sheath 511.In the configuration, ultrasonic imaging ripple is by internal layer and outer layer, and supersonic melting ripple only passes through outer layer.Remote point The distal ends that end 518 is connected to echoless housing, and can have circular distal in order to transport through sheath and blood vessel and It is conveniently attached to the frame that the diameter of housing reduces, it is allowed to the concordant transition on outer surface.Distal end can be by the impermeable of softness The Pebax of ray is made, and when using X ray or fluoroscopy, it can be visualized.

In the alternate embodiment as shown in Figure 12 H, outer layer 550 can be had before ablation transducer 552 Projection 551 sacculus (such as nylon), compared with the housing without projection, it can allow to melt between transducer and vascular wall Bigger fixed range and preferably cooling.Projection can offset about 1mm.

In alternate embodiment as shown in figure 12i, echoless housing can include outer layer 566, and outer layer 566 can be The thin layer of the substantially anechoic material (for example, nylon, PET, LDPE) of 0.001 " (for example, about 0.008 ") can be less than, And internal layer can include two layers 567 and 568 for clipping fiducial marker 569.Two layers 567 and 568 can be about 0.0025 " is thick, and can be made up of the material of such as nylon, with that can launch the imaging transducer of IVUS conduits 526 Ultrasonic wave is that substantially anechoic outer layer 566 combines.

In an alternate embodiment, anechoic room can include supersonic melting transducer, but not include imaging transducer. IVUS inner chambers may be configured to the ultrasonic imaging transducer of IVUS conduits being placed near ablation transducer, but be connect with blood flow Touch.Fiducial marker can be located in the visual field of imaging transducer, and can be such as seal wire.

Fiducial marker 516 can be placed on to the precalculated position of the sighted direction 517 relative to ablation energy so that Artifact is produced on image or video based on ultrasound, indicates relative boresight side of the ablation energy relative to the anatomical structure of imaging To.As shown in Figure 12 A and 12F, fiducial marker 516 can be the strip of echo opaque material (for example, about 0.080 " Wide, 0.002 " thick and 0.5 " long bent-strip, and be cut by laser from stainless steel tube), it is sandwiched in the internal layer of echoless housing Between 540 and outer layer 539 and it is positioned to diametrically opposite with the sighted direction of ablation energy.A kind of alternate design is included about 0.0025 " two thick nylon inner layers, one of fiducial marker is between two internal layers, and two internal layers are melted in one Rise, embedded in fiducial marker.This can prevent reference mark from damaging relatively thin outer layer.Disclosed herein is replacing for fiducial marker For embodiment.

In the proximal region of ablation catheter, sheath may be coupled to nearside manifold, and it is also used as shown in fig. 12g Handle 544.Handle can have the electric wire that will be used to melt transducer and sensor (for example, temperature sensor) by interconnecting cable 547 are connected to the electric connector 545 of ablation console 546, the IVUS ports 548 with haemostatic valve, cooling agent input port 549 With the cooling agent output port 555 for being connected to coolant hose group 556.Pipe group can be connected to by pump (such as peristaltic pump) 562 Coolant supply 561 and cooling agent abandon container 563.Ultrasound imaging catheter (such as IVUS conduits) 526 can be inserted into In IVUS ports 548 and imaging control console 559 is connected to, imaging control console 559 can be optionally coupled to image enhancement algorithm With display 560 or ablation console 546.Handle 544 can promote the rotation process of ablation catheter.Memory storage element 557 (such as including the EEPROM with time and unique lesion depths table of power setting) in the handle and can be connected to electricity Connector is with melting console communication.Handle can include being used for what is managed electrical connection and comprising EEPROM and such as connect Equipment detection, using limitation (for example, recycle prevent, limited using duration, the use of limited quantity) and will make be The circuit board 558 for the electric match circuit that reflected energy in system minimizes.Ablation catheter 544 is inserted into deflectable conveying In sheath 564.

Optionally, ablation catheter can be configured with the device for entering horizontal deflection or conveying by seal wire, such as pass through this Illustrated in embodiment disclosed in text.

The imaging beam being aligned with ablation beam

The embodiment of carotid body supersonic melting conduit can include the distal area for being transported to the vascular system of patient Domain and the proximal end region being retained in outside body.Remote area be suitable to from supersonic melting transducer transmit ablation ultrasonic energy and from IVUS imaging catheters transmit ultrasonic imaging signal.The conduit is configured to provide the organization chart picture close to remote area, the distal end Region is aligned and oriented with the sighted direction of ablation transducer.User can search for simultaneously to the imaging of tissue around remote area Identify target ablation region (for example, arteria carotis spacer film), directional catheter so that ablation transducer run-home ablation areas, And ablation ultrasonic energy is transported to target ablation region.In fig. 13, remote area 320 includes echoless housing 321, and it can To be such as thin polymer or sacculus.Cavity in housing, which defines, to be filled out with cooling agent (such as circulating brine or sterilized water) The anechoic room 322 filled.For example, cooling agent can convey via cooling agent conveyor chamber 332 and discharge the row of chamber 333 via cooling agent Go out.There is the supersonic melting transducer 323 for being installed to backing 324 in anechoic room, backing 324 is ultrasonic barrier material, such as Stainless steel or the epoxy resin containing air microballoon.Supersonic melting transducer aims in generally radial direction so that when disappearing When melting ultrasonic energy and being launched, it is transmitted along sighted direction 325.Supersonic melting transducer or backing can be installed to sheath On 326, such as on the bar (such as hypotube) that is inserted into the inner chamber in ablation catheter sheath of as shown being installed to or install On manifold part (not shown).

Carotid body supersonic melting conduit can include elongated sheath 326, and elongated sheath 326 can be by the polymer that extrudes It is made, and can be with long enough (for example, about 100 to 120cm), with quiet from stock when being transported to jugular vein 12 by vena cave Arteries and veins is to reach the neck of patient.The jugular vein general diameter of the mankind is about 8 to 20mm.Sheath may be configured to be suitable for neck Vein, such as the diameter with less than or equal to about 18French (for example, between about 9 and 11French).Conduit can pass through Delivery sheath 327, the delivery sheath that can be turned to are conveyed by seal wire 328.Sheath can include IVUS inner chambers 329, and it can be slided IVUS imaging catheters 330 are received dynamicly.Inner chamber can extend to the anechoic room of distal end regions from the proximal end region of conduit. IVUS imaging catheters can be inserted into IVUS inner chambers in the proximal end region of ablation catheter (for example, in the handle), and are passed through IVUS inner chambers are advanced to remote area.IVUS inner chambers can be oriented in echoless shell chamber so that the imaging of IVUS conduits is changed Can sighted direction positioning of the device 331 along ablation transducer.

As shown in Figure 14 A, can be for example sharp by IVUS imaging catheters 330 in the proximal end of conduit 334, IVUS inner chambers 329 Entered with the port 335 comprising haemostatic valve, and can included and the mating feature part 337 on the near-end of IVUS imaging catheters The mating feature part 336 of cooperation so that when IVUS imaging catheters are fully-inserted, mating feature part coordinates and IVUS imaging catheters Distal end be appropriately positioned in the remote area 338 of supersonic melting conduit.Mating feature part on IVUS imaging catheters can be with Be attached on conduit, or it can be located in the sheath of IVUS imaging catheters and be fastened on desired position with Make the single adapter of depth stop.The mating feature part of ablation catheter can be in the extended position and figure shown in Figure 14 A Moved between retracted position shown in 14B so that in extended position, IVUS imaging transducers align and prepared with ablation transducer To target imaging；And in retracted position, IVUS imaging transducers are led by the distal end removal ablation being enough IVUS imaging catheters Pull to the near-end of ablation catheter the sighted direction of pipe.Actuator 339 on handle can be used for the IVUS conduits that promote or retract.Can Selection of land, IVUS imaging catheters can manually advance and retract.

Supersonic melting conduit can also include the echoless that cooling agent such as salt solution or sterilized water are transported to remote area The device of room 322.For example, sheath can include cooling agent conveyor chamber 332 and cooling agent return cavity 333.Cooling agent conveyor chamber and The cooling agent delivery port 339 and cooling agent that return cavity may be coupled at the proximal end region of ablation catheter return to port 340. Cooling agent can pass through the container including coolant source such as salt solution or sterilized water, pipeline such as pipeline and pump such as peristaltic pump Coolant system is supplied to conduit.Coolant system can also include flowing ripple damper or flowmeter.Coolant system can With by user's control, or it can be automatically controlled by console 341, console 341 coordinates conveying and the ultrasonic energy of cooling agent Conveying.For example, cooling agent can start the cycle over before ablation energy conveying, its speed and time are enough to ensure that cooling agent exists Ablation energy is circulated before transmission in anechoic room, and at least continues until that ablation energy stops.Other signals also may be used For controlling cooling agent, such as the temperature of supersonic melting transducer or anechoic room.

Supersonic melting conduit can also include ablation transducer being connected at the proximal end region of conduit (for example, in handle On) electric connector electric conductor.Conductor can be maintained in the inner chamber of sheath or the inner chamber of hypotube (not shown).Can be with Other conductors, such as sensor conductor be present.Temperature sensor can be positioned in anechoic room (for example, in echoless housing On surface, in ablation transducer face), it can be with measurement temperature.Temperature survey may be used to indicate enough power, excessive Power or overheat.Temperature signal can be used for control to be conveyed to the power of ablation transducer.

Alternate embodiment as shown in figure 15 can include the manifold part 345 of machining, and it can be by such as not The dense material of rust steel is made can be made up for use as ablation transducer backing, or manifold part of plastics such as PEEK, and Thin transducer backing can be added.Manifold part can be the cylinder for having cut-out, and it is 346 groups with echoless housing Anechoic room is defined in conjunction.By echoless housing (such as polymer sleeve pipe, film of the thickness in the range of about 0.0002 " to 0.009 " Or sacculus) be placed on around cut-out, to form anechoic room and accommodate circulating coolant.Manifold part is all with being adhered to Such as the device of the polymer sheath of lip 347, it can have the barb for being attached to sheath 348 or hole or windowing to receive sheath The backflow of tube material.Manifold part includes the IVUS inner chambers 349 connected with the IVUS inner chambers in sheath.As shown, ablation is changed Energy device 350 can be installed to manifold part 345, and manifold part can have recessed housing 351 or profile, put wherein Ablation transducer is put in order to manufacture.Manifold part can also include with the coolant cavity in sheath connecting when connecting manifold part Logical cooling agent conveyor chamber 352 and return cavity 353.Manifold part can also have inner chamber to carry electric conductor (for example, with connection To the sensor conductor of ablation transducer or such as temperature sensor).The distal tip 354 of manifold part can be circular. IVUS inner chambers be can be positioned in machined piece so that inner chamber is centrally located on the sighted direction of ablation transducer, the party To be considered from ablation energy converter planar center send perpendicular to ablation energy converter planar straight line.In extended configuration Under, the height of the IVUS imaging transducers 355 of IVUS conduits 358 can align with melting the sighted direction of transducer, such as Figure 15 institutes Show.

Optionally, supersonic melting conduit may include the device that will be transmitted by seal wire 356.As shown in Figure 13 or 15, conduit Guidewire lumen 357 that can be on the side of sheath or alternatively in sheath can be included.

The example for the image that the IVUS imaging catheters being deployed in supersonic melting conduit provide is shown in Figure 16.Line is cloudy The dark space of shadow zone domain representation ultrasonoscopy, including the wedge-shaped shade 360 projected by ablation transducer or back lining materials, receiving conduit Blood vessel 361 (for example, jugular vein, facial vein), internal carotid 90 and external carotid artery 91.Melt the sighted direction of transducer The center of 362 artifacts opposite with the shade projected by ablation transducer and through IVUS imaging catheters 363.As shown, disappear The sighted direction 362 for melting transducer is placed towards arteria carotis barrier film 205 by the orientation for melting conduit, and arteria carotis barrier film 205 is in neck And can be in about 7 or 10mm above carotid bifuracation between interior artery and internal carotid.When conduit travels across blood vessel (example Such as, jugular vein, facial vein) and internal carotid and external carotid artery can recognize carotid bifuracation when merging.Away from arteria carotis The distance of bifurcated can for example determine that the distance can be disappeared by carotid body ultrasound by the way that conduit is promoted about in 7mm Melt the sounding mark that is associated in the sheath of conduit with delivery sheath (not shown) to measure.Once orientation and the position of ablation catheter The sighted direction that target area is directed to according to ablation transducer is placed with being expected to, then IVUS imaging catheters regracting, so as to The distal tip of IVUS imaging catheters is removed from anechoic room, or do not stop ablation signal at least, and supersonic melting energy Target area can be sent to from ablation transducer.

Supersonic melting conduit can be adapted to move remote area articulated type.Articulated type movement can promote to melt transducing Device extends ablation to the positioning of target alignment or by producing multiple ablation sites related with multiple articulated type shift positions Area.For example, ablation catheter can include controllable deflection, wherein deflectable length 366 (for example, about 1 to 3cm) is from a lateral bending It is bent to opposite side, up to deflectable distance 367 (for example, about 0.5 to 3cm).As shown in figure 17, deflection can be with melting transducing In the coplanar plane of device.It can be realized by being connected to the bracing wire of remote area 368 (for example, to manifold part) controllable inclined Turn, the inner chamber being drawstring through in sheath to proximal end region, the deflected actuators that they may be connected on handle 370 in this place 369, it applies tension force to deflect remote area to bracing wire.Deflectable catheter can include the device of rotary guide pipe sheath, such as Revolving actuator 371.

Deflection can be configured in and melt the plane of transducer substantially orthogonal to plane in, or can be configured in The placement for potentially contributing to treat transducer, the generation repeatedly melted, produce bigger ablation or manipulate or deformation includes conduit Blood vessel (for example, vein, jugular vein, facial vein) any other direction on, supersonic melting transducer is placed on suitable When position to deliver energy to target or place ultrasonic imaging transducer in position to identify target or the target area Tissue in domain.

Ablation transducer with angle

As shown in figure 18, being configured to the alternate embodiment of the ablation catheter 375 of ultrasonic imaging and treatment can include It is configured as receiving the IVUS chambers 376 of single ultrasound imaging catheter (for example, IVUS conduits) 377, wherein imaging transducer 378 The anechoic room 379 and ablation transducer 380 being advanced in the distal region of ablation catheter are located remotely from imaging transducing In the anechoic room of device and into causing launched supersonic melting energy to be guided through the angle of imaging plane 381.Imaging Plane can be approximately perpendicular to the disk of the axis of imaging catheter.Alternately, IVUS conduits can be configured as making imaging Transducer somewhat (for example, about 85 degree from IVUS conduits axis rather than perpendicular to axis) is angled, produces somewhat conical Imaging section (slice).In figure 18, ablation transducer 380 is positioned at the distal side of imaging transducer and into so that being produced Raw zone of ablation 382 is directed into the angle intersected with imaging plane or section.Alternatively, ablation transducer can be positioned at into As transducer nearside and into causing zone of ablation to be directed into the angle intersected with imaging plane or section.Melting transducer can To be rectangle, there is fillet, or egg shape or circular shape.For example, it is being configured as melting carotid body or arteria carotis barrier film In embodiment, zone of ablation can intersect with the imaging plane on the surface away from imaging catheter about 3 to 8mm (e.g., from about 5mm), should be away from From can be suitable distance from the conduit in jugular vein 12 or facial vein to target area 205.Exemplary configuration can be with Including 4mm length and ablation transducer wide 2mm.Ablation transducer can be placed as with axle between about 40 ° to 50 ° (such as About 45 °) angle 383 and imaging plane distal end at a distance of about 3 to 10mm (e.g., from about 5mm) distance 384.Can produce has The ablation areas of the elongated shape extended substantially perpendicular to the surface of ablation transducer.The advantages of embodiment may include, To the ability of target area imaging while ablation energy is transmitted, or ablation energy first is then transported on to target area imaging Without mobile imaging catheter, this can leave the risk of target to improve security and work(by reducing mobile ablation energy Effect.In addition, the angled ablation in target area can surround the more volume of target area while not extend off target Region.Reduced conduit diameter can be allowed by being placed on the angled ablation transducer of imaging transducer distal end.Similar In embodiment, imaging transducer is desirably integrated into ablation catheter, is advanced to not as independent conduit in ablation catheter.

In the embodiment illustrated, ablation catheter 375 includes made of pressure polymerization thing sheath (such as with about 11F external diameter), with flexible hardness (soft durometer), have and be used to improve torque response (torque Response braided sheath layer).The IVUS tube chambers 376 that sheath includes being used to receive the conduit of ultrasonic imaging 377 are (for example, about 9.5F).The tube chamber can also be used for cooling agent and pass through.Ablation catheter can also include the guidewire lumen 385 for being used for conduit conveying on line (for example, with the lumen diameter for slidably receiving 0.018 " seal wire).Guidewire lumen can be in pipe (for example, polyimide tube) Tube chamber, through the inner chamber in sheath and pass through the distal end of anechoic room to conduit.Ablation catheter can include cooling agent and convey Chamber, it can be the chamber in cooling agent delivery pipe, by the cooling agent of such as salt solution or sterilized water be stored in anechoic room (for example, Away from ablation transducer) in.Cooling agent in anechoic room and can flow cocurrent and go out cooling agent discharge chamber, cooling agent row It can be imaging catheter conveyor chamber to go out chamber.Temperature sensor (for example, thermocouple, thermistor) can be placed in anechoic room (for example, ablation transducer on, on locular wall), with monitoring temperature and ensure that enough cooling agents are conveyed to avoid overheating. Point of aim mark 386 can be positioned in imaging plane, adjacent with imaging catheter conveyor chamber, and the direction conveyed with ablation energy Conversely.Point of aim mark device can be by being made, to be produced on the video based on ultrasound with the material of imaging ultrasound wave interaction Unique image.For example, point of aim mark device can by absorption ultrasonic wave material or for ultrasonic wave strong reflection thing material It is made.The unique image or artifact of the displaying point of aim mark device shown on video based on ultrasound can be instruction ablation transducers The shade or bloom aimed in the opposite direction.It is contemplated that create the other configurations clearly identified to sighted direction.

One example of application method can include sheath 387 being advanced to close to mesh target area；By ablation catheter 375 It is advanced to the interior intracavitary of sheath；Imaging catheter is advanced in the inner chamber of ablation catheter, returned until imaging transducer is positioned at nothing In sound chamber；The ablation catheter containing imaging catheter is disposed from the distal end of sheath；While imaging using imaging catheter, using by sheath The combination that pipe promotes and retracted together with the ablation catheter comprising imaging catheter, and sheath is deflected and reversed to obtain relative to disappearing Melt the correct position of target；Ablation catheter is reversed while imaging, transducer run-home will be melted.It is alternatively possible to Use seal wire.For example, seal wire can be first transmitted, and sheath and conduit can transmit on seal wire.

Imaging transducer with angle

Alternate embodiment includes the imaging transducer 390 being angularly positioned with ablation catheter sheath 391.Individually ablation Transducer 392 can be parallel to ablation catheter sheath or into angle as shown in figure 19.Melt transducer and imaging transducer edge Conduit axis and be spaced from each other a distance placement, and they are at an angle to each other so that ablation areas 393 and imaging region 394 radial to one of ablation catheter, apart from upper overlapping, the distance is adapted to melt 395 targets (for example, from vein from blood vessel 12 Such as jugular vein or facial vein ablation carotid body target).In the embodiment illustrated, imaging catheter 396 is advanced through Inner chamber in ablation catheter.In the distal region of conduit, inner chamber is worn in conduit lateral bend and by the port 397 of the conduit side Go out.The imaging catheter pass-out port, and the imaging transducer 390 on imaging catheter is positioned to the sheath of ablation catheter into one Angle.Overlapping imaging and ablation areas allow simultaneously to target imaging and ablation.Between imaging transducer and ablation transducer Angle can by ablation catheter diameter, ablation the distance between transducer and imaging transducer and it is expected ablation size determine It is fixed.The angle can be for example between about 90 ° and 150 °.The embodiment can allow ablation catheter with than being changed with ablation Energy device and imaging transducer position and in the design less diameter of substantially the same axial location adjacent to each other.The implementation Scheme can also allow for using imaging catheter, and the imaging catheter has the long part away from its imaging transducer, suppresses imaging and changes The appropriate alignment of energy device and ablation transducer.Long distal portions can protrude from tube chamber outlet.

Because the distance between vein and target area may change, it is suitable to realize vein can be manipulated as described herein When position and distance.Alternatively, ablation catheter may be configured to tilt ablation transducer to realize at suitable distance Ablation.For example, multiple conduits can be provided, it is disposed for produce ablation with the different distance and angle of ablation catheter.

Pivot ablation transducer

Be configured as receive imaging catheter 358 supersonic melting conduit 400 embodiment can have can pivot with Change the ablation transducer 401 of the angle 402 relative to axis, as seen in figs. 2 oa and 2 ob.User can be closely last by conduit Actuator (for example, lever, driver plate, button or knob on handle) on end controls pivot (pivot), and it is for example by tension force Being applied to makes transducer be pivoted to another angle or the bracing wire to multiple positions therebetween from an angle.As shown in FIG. 20 A, Transducer 401 is melted positioned at the side of imaging transducer 355 of stretching, extension.In this arrangement, according to anatomical structure and the position of conduit Put, device can use in many ways.Alternatively, as shown in fig. 20b, the imaging transducing of stretching, extension can be located at by melting transducer The distal side of device.Pivot can be included in the hinge or pivot hinge 403 of the proximal end of transducer backing.Spring will can change Can device be pushed to first position (for example, with angle with about 45 degree of axis).It is slidably retained in the inner chamber of conduit simultaneously The wire for the actuator being connected on catheter proximal end can be promoted to engage and stretch pivot transducer or be pulled to release With the engagement of transducer, it is allowed to which it is bound to its angled configuration.The angle or ablation transducer of ablation transducer can be adjusted Relative position with imaging transducer is with the intersection point of mobile ablation beam 404 and imaging plane 405.

IVUS compatibility

In the market has a variety of IVUS conduits.It is configured as receiving the ablation catheter of intravascular ultrasound imaging conduit can be special Ground is configured to receive in the market available IVUS conduits, such as VolcanoPV.035 IVUS conduits or Boston Scientific Corporation'sIVUS conduits.

Visions PV.035 IVUS conduits have imaging transducer in its remote area.Imaging plane is apart from the distal end About 13.5mm.The bore of transducer is 8.2FR and length is about 6.5mm.The distal end from the near-end of transducer to conduit away from From for about 18.5mm.Conduit sheath is 7.0FR, and active length is about 90cm.Imaging transducer is made up of 64 yuan of cylindrical-arrays. Conduit has the guidewire lumen that near-end is extended to from its remote tip.It is configured to receive disappearing for Visions PV.035 IVUS conduits The IVUS chambers with minimum diameter about 8.5FR can be included by melting conduit, and preferably in the same lumen of IVUS surrounding catheters In have be used for cooling agent return exceptional space.Space in anechoic room can be with long enough to accommodate imaging transducer and lead Part of the pipe away from transducer.For example, the distance from the remote edge of manifold part to end pieces can be at least 18.5mm (examples Such as, about 19mm).The length of ablation catheter can allow imaging transducer to be positioned in anechoic room, while IVUS conduits is near Y-connection on end extends from the near-end (for example, proximally handle on region) of ablation catheter.For example, ablation catheter from The length of IVUS ports on distal-to-proximal can be no more than about 90cm but long enough with from introduce position (for example, femoral vein) Reach target area (for example, in jugular vein near carotid body), while be inserted through deflectable delivery sheath. Valve such as haemostatic valve on the IVUS ports of ablation catheter should be configured to permit 8.5FR transducers by while surrounding 7FR Sealing is to prevent in the case where being for example up to about 30psi pressure cooling agent from leaking.The guidewire lumen of IVUS conduits can use cooling agent Perfusion, and sealed in near-end Rule cap to prevent cooling agent leakage or air from entering.

Ultra ICE IVUS conduits have the single 9MHz imaging transducers being arranged on rotation driving axle, and the rotation is driven Dynamic sheath is through the sheath of IVUS conduits to its proximal end region, and it is connected to motor with rotatable transducer in this place.Transducer Into the angle for being slightly toward distal end.Imaging plane is apart from the distal end about 5.5mm.However, because transducer is at an angle of, so image It is the cone rather than transverse plane of slightly distal end.The bore of transducer is 9FR and length is about 2mm.From the near-end of transducer Distance to the distal end of conduit is about 9.5mm.Conduit sheath is 9FR and active length is about 110cm.It is configured to receive The ablation catheter of Ultra ICE IVUS conduits can have the IVUS chambers of about 9FR minimum diameter, and preferably in IVUS Have in the same lumen of surrounding catheter and be used for the exceptional space that cooling agent returns.Space in anechoic room can with long enough with Accommodate the part of imaging transducer and conduit away from transducer.For example, from the remote edge of manifold part to the distance of end pieces Can be at least 9.5mm (for example, about 10mm).Be considered as imaging transducer angle how relative to image modification target position Put.The length of ablation catheter can allow imaging transducer to be positioned in anechoic room, while the company on the near-end of IVUS conduits Device is connect from the near-end (for example, proximally handle on region) of ablation catheter to extend.For example, ablation catheter is from distal end on near-end IVUS ports length can be no more than about 110cm (e.g., from about 104.5cm+/- 2cm) but long enough with from introduce position (example Such as, femoral vein) target area (for example, in jugular vein near carotid body) is reached, while be inserted through deflectable Delivery sheath (for example, length available with about 93.5cm+/- 2cm).Valve on the IVUS ports of ablation catheter is such as Haemostatic valve should be configured to permit 9FR sheaths by while around its sealing to prevent in the case where being for example up to about 30psi pressure Cooling agent leaks.Because imaging transducer rotates on the driving shaft, therefore it should be noted that avoid grasp drive shaft or prevent its rotation. For example, ablation catheter can be configured with the bending radius or flexibility of minimum., can relative to the proximal end region of ablation catheter To provide the part of the proximal region comprising motor (motor drive) and IVUS conduits to avoid twisting together.

System

Interconnection cable, delivery sheath, coolant hose group, cooling medium pump and ablation control can be included by supporting the system of ablation catheter Platform processed.Embodiment for being configured as receiving single imaging catheter, the system can include imaging catheter and imaging is controlled Platform processed, or these can be provided separately.For being configured to the embodiment with integrated imaging transducer, imaging control console It can be integrated with ablation console or single unit.The other assemblies used in a program, for example, cooling agent (such as IV bags or Sterilized water or salt solution in bottle), introducer, scene prepare supply (site preparation supplies) and dressing, can To provide in kit or be obtained from the source of supply of software.System can also include being used to handle trouble relative to trunk The head of person and the support of neck.Embodiment for being configured to be used together with seal wire, system can include a seal wire Or one group of seal wire is (for example, the seal wire with 0.018 " diameter or 0.035 " diameter, the seal wire with preforming bending, deflectable Seal wire).

Interconnection cable can be configured as ablation catheter being connected to ablation console, such as with cooperation fast coupling connector With suitable conductor.It can be suitable length (e.g., from about 8 ') to interconnect cable, and ablation console is separated with aseptic area, and Without prejudice to conduit operability during program.

Delivery catheter can deflect at least one direction.It can have soft (for example, about 35D hardness), It is atraumatic tip, the tube chamber with the diameter (e.g., from about 0.174 ") for being suitable to slidably engage ablation catheter, corresponding outer Footpath (for example, about .210 ") and the valve (for example, Tuohy-Borst valves) for allowing ablation catheter to pass through.

Coolant hose group can be mutually compatible with cooling medium pump, such as with being fed by peristaltic pump and and peristaltic pump The part worked together.Coolant hose group can include luer lock and connect, itself and commercially available IV solution managements set group and expansion It is compatible to open up set group.Pipe group may include the cooling agent delivery port that cooling agent is transported to ablation catheter handle from pump line part Pipe.The part of pipe can also include pressure relief valve, to be beaten in the case where being for example not intended to the high pressure as caused by catheter blockage Open.The part can also include ripple damper.Coolant hose group also includes the cooling agent that will be connected to ablation catheter handle Return to the cooling agent recurrent canal of port.Cooling agent can be returned to cooling agent storage container or be abandoned by cooling agent recurrent canal. In one embodiment, cooling agent storage container only includes the enough cooling agents for being enough to be used in limited amount ablation, and returns Return cooling agent to be dropped, therefore in the case of tube leaks, only limited amount cooling agent is transported in the blood flow of patient.

Ablation console can be the electric signal generator of computerization, and it transmits high frequency (example to supersonic melting transducer Such as, in the range of about 10 to 25MHz, about 20MHz) alternating current.Energy-delivering parameter can be selected by user or can be with Automatically determine.For example, console can read data from the memory in conduit, and correspondingly convey energy or with expectation Parameter for example lesion depths combine.Console can also coordinate cooling agent pumping or imaging capability.Console can identify instruction The condition of catheter malfunction or undesirable program simultaneously reminds user or the conveying of adjustment energy to subtract solution problem.Console can by with It is set to and nerve stimulation signal is delivered to conduit.For example, mechanically or thermally stimulate the ultrasonic signal of nerve can be in not ablation tissue In the case of transmit, to determine effective or safe aiming of the ablation transducer before ablation energy is conveyed and confirm after ablation Successful ablation.Alternatively, conduit can include one or more stimulating electrodes, and console can convey electrical nerve stimulation Signal with assess with nerve the degree of approach.

Vein is manipulated to obtain suitable ablation locations

The configuration of vein near target site can be different because of different patients, can also be different because of the not homonymy of patient. The ablation catheter 411 of all any embodiments of supersonic melting conduit as disclosed herein can be transported to close to target site 205 and the vein 12 in the correct position for carotid body ablative surgery.For example, the condition of correct position can include From the inner surface of wall of vein to the distance 410 on the target site such as border of arteria carotis spacer film in about 0 to 5mm, and it is quiet Arteries and veins 12 and target alignment are to allow ablation energy to convey and accessible or unsafe interference.The condition of replacement of correct position can use Certainly in the construction of ablation catheter.In some patients, in place in may there is no vein, however, ablation catheter can be with The vein of correct position can be being maneuvered to by being transported to.Vein or intravenous catheter steering can be wrapped to suitable position Include such as following technology：Stereognosis neck, rotatable head, deflectable ablation catheter is deflected, deploy the knot from ablation catheter For example extensible line of structure, deflects deflectable sheath, or these combination.

As shown in Figure 21 A to 21B, deflectable sheath 412 is configurable to be used to deflect at least one direction, has About 9FR to 16FR external diameter, and there is inner chamber to slidably engage ablation catheter 411.Sheath can have elongated portion 413 and the deflectionable part 414 that passes through with central lumen.Braiding chuck can surround elongated portion to improve torque response. Actively deflection can be realized by bracing wire, and the handle of the bracing wire tube chamber being drawstring through in sheath proximally reaches deflectable portion The anchoring piece of the far-end divided.Tension force can be applied to bracing wire by the actuator on handle.Handle can also promote twisting to grasp Make, and including inner chamber with the clamp adapter of such as Tuohy-Borst connector receiving ablation catheter.Sheath can be in sheath The remote area of pipe nearby or in its distal end regions includes deflectionable part 414.Deflectionable part can be with e.g., from about 1 to 5cm Between long (for example, about 3cm grows), and be located at the distal end of sheath as shown in figures 21a and 21b.

Figure 21 A show the ablation catheter 411 that jugular vein 12 is transported to by the deflectable sheath 412 of non-deflected state, Wherein destination organization 205 is insufficient to close to ablation transducer 415.Figure 21 B show the deflectable sheath in deflection state 412, ablation catheter 411 is pressed against wall of vein and manipulates extendable vein to obtain between destination organization and ablation transducer by it Suitable distance 410.In such configuration, ablation catheter 411 can have a bendable portion 416, and the bendable portion 416 is curved It is bent to allow the conduit away from bendable portion 416 to be alignd with vascular wall, it is but hard enough to manipulate it to vein applying power Position.For example, bendable portion 416 can have the hardness in the range of about 40D to 55D (for example, about 50D).

Alternatively, as shown in fig. 21 c, deflectionable part 421 can near the distal region of deflectable sheath 420, and And soft passive deflectionable part 422 can be in the far-end of sheath.Soft, passive flexible portion can provide and wall of vein Hurtless measure contacts, while sheath is deflected and is pressed against wall so that vein to be manipulated to the appropriate location for carotid body ablation.Soft Passive flexible portion can also allow for the distal openings of sheath to be alignd with vein so that the ablation catheter such as institute conveyed by sheath Leave sheath enough with showing parallel to wall of vein.Soft passive flexible portion can by than elongated portion (for example, about 63D is hard Degree) and softer (the e.g., from about 35D hardness) polymer of deflectionable part (for example, about 50D hardness) hardness be made.Passive flexible part The length divided can be in the range of about 1 to 3cm (for example, about 2cm).The length of deflectionable part 421 can be about 2 to 5cm In the range of (for example, about 3cm).

Method using the deflectable sheath with ablation catheter can include, and sheath is quiet from the entrance of such as femoral vein Arteries and veins is transported to the vein close to target, such as quiet in jugular vein, facial vein or the neck that is connected near carotid body Other veins of arteries and veins.The all embodiments of ablation catheter as described herein of conduit are configured to be used together with imaging catheter Ablation catheter can be conveyed by deflectable sheath.The imaging mould (imaging modality) being positioned in ablation catheter Such as IVUS conduits can be used for being imaged the tissue for melting surrounding catheter, and identify the relative position of target.If desired Vein is manipulated to reach the correct position for target ablation, can be followed the steps below or the combination of step：Sheath can be inclined Transfer part point can be deflected by controlling actuator；It is deflectable that sheath can be twisted to torsion distal side at near-end or handle End；Ablation catheter can be pushed into or be retracted in sheath to obtain from the deflectionable part of sheath to the suitable of ablation transducer Distance；Ablation catheter can be twisted to the sighted direction of rotation ablation at its near-end or handle；And if ablation catheter quilt It is configured to deflectable, then it can be deflected.It can continue to be imaged when manipulating vein, or can intermittently perform into Picture, until obtaining gratifying position.Position to ablation can be carried out during or after satisfactorily manipulating in vein Put the adjustment with sighted direction.For example, ablation catheter can be rotated, promoted, retracted or be deflected, will melt energy in imaging Measure run-home.

It is configured as being imaged and melts the transducer element of the two

Supersonic melting conduit can include being arranged to be imaged and melting the transducer assemblies of the two.As shown in figure 22, It is configured to permit the transducer assemblies of imaging and ablation ability to include first transducer 425, second transducer 426, the back of the body Lining component 427 and electric conductor A, B and the C as depicted for being connected to the first and second transducers.Can by with 1/a into than The frequency (for example, about v/2a) of example applies RF signals to realize the ablation vibration of the high power of first transducer to electrode A and B, its Middle v is the velocity of sound in first transducer and a is the thickness of first transducer.Can the second of one or more transducers change Energy device is sandwiched between first transducer and backing member, and backing member provides the function and imaging energy of installation first transducer Power.The lower frequency proportional to 1/ (a+b) is (for example, about v/2 (a+b) or imaging v/2b) pass through respectively via electrode pair AC Or the vibration of BC sensing transducer assemblies realizes that wherein b is the thickness of second transducer.Thickness c backing member (wherein c The reflector that more than a or b) is mainly used as in ablation mode and as the absorber in imaging pattern.The outer surface of backing member With scattering and surface characteristics (such as texture, angled ridge) of the input signal away from imaging transducer region is redirected, from And reduce the ringing effect inside backing member.The inner surface of backing member can be flat and be mirror-finished to strengthen Reflectivity at about v/2a ablation operation frequency.Backing member (not accommodated by second transducer otherwise) and the Optional gap between one transducer can use air or liquid to fill.

For example, that as shown in Fig. 5 to Fig. 8 of the embodiment of the supersonic melting conduit with integrated imaging transducer A bit, one group of imaging transducer as depicted can be included, but be that instead of melting transducer, the conduit can have and can carry out It is imaged and melts the transducer assemblies of the two.This can allow transducer assemblies accurately to produce the place being directed in ablation The image of tissue.It is configured as receiving the supersonic melting of single ultrasound imaging catheter (such as those shown in Figure 11 to 20) to lead The similar embodiment of pipe can include being arranged to melt and being imaged both transducer assemblies.

Alternatively, as shown in figure 23, ablation catheter 430 can be not present one group of imaging transducer or for receiving individually The device of ultrasound imaging catheter and only have be arranged to be imaged and melt the transducer assemblies (Figure 22) 424 of the two. In this configuration, compared with the embodiment with single imaging capability, it may be more difficult to observe the tissue of surrounding target, but It is that such configuration can have advantage in terms of cost and ease for use.Due to the embodiment phase with surrounding imaging capability Than, single transducer component has the ability for producing amplitude modes linear image (amplitude mode line image), because This user can manipulate conduit for example transducer assemblies from side to opposite side are swung or promoted by reversing conduit or Retraction conduit obtains multiple line images of surrounding tissue.Alternatively, conduit can be configured as remains stationary, while have into Picture and the transducer assemblies of ablation functionality aim at the different directions in conduit.Worn for example, transducer assemblies can be installed to Cross the bar of conduit sheath, it can be rotated by 360 °, or in predetermined hole, such as in an angle of 90 degrees it is tilted.Alternatively, transducing Device assembly can move (such as tilt, deflect, rotation) in multiple planes in conduit.This movement can be used for catching The image of the tissue of surrounding target is obtained, it is either that transducer assemblies run-home or mobile transducer assemblies is multiple to carry out Ablation, or transducer assemblies are swung to expand ablation.

Supersonic melting dosimetry and deep-controlled

Laboratory and zooscopy has been carried out in author, using using size as about 2mm is wide and 4mm to 6mm grows transducing Device assesses the dosimetry of supersonic melting energy.Power between 3 to 8 sound watt, the frequency in about 10MHz to 25MHz scope Time range between rate and 5 seconds to 20 seconds can allow in 2mm to the rational controllable trauma depth between 9mm and by transducing What device width and length determined is suitable for targetting arteria carotis barrier film (for example, positioned at away from jugular vein inwall about 2-9mm's from jugular vein Tissue) lateral dimension.

Control the effect of ability of depth of ablation is for clinical operation and security most important.In view of arteria carotis, neck move The notable anatomical variations of arteries and veins body and jugular relative position, depth of ablation control for effective ablation targets tissue (such as Arteria carotis barrier film), while ablation areas is safely limited to avoid being to the iatrogenic injury of important non-targeted nerve or tissue Important.Theory is formed according to damage, humidity index is defined as with the time by thermocoagulation region caused by Ultrasonic Heating Integrate [Sapareto S.A., Dewey W.C.Thermal dose determination in cancer therapy Int.J.Radiat.Oncol.Biol.Phys.1984.V.10.№Bi P.787–800].As caused by flat rectangular element Damage starts to travel to the deeper tissue farther away from transducer along supersonic beam depth near transducer and with the time.Use Thermal dose defines, and theoretical lesion depths can pass through the integration rough estimate with the time：

Wherein d is the depth of damage, and T is tissue temperature, and t is the time.Based on finite element modelling, the group changed over time It is substantially proportional to the acoustical power of application and the product of ablation time to knit temperature：

T~Pt^β (2)

Wherein β is the dimensionless coefficient that tissue and transducer rely on, less than or equal to 1.(it is applied in simplest β=1 Active ultrasonic power deposition (active ultrasound power deposition) with insignificant volume heat transfer) In the case of composite equation (1) and (2), lesion depths provide as the acoustical power and the function of ablation time applied：

Assuming that β deviate 1, the growth of the lesion depths of more complicated form over time can be derived, this correspond to by compared with For a long time with the ablation of lower-wattage composition, wherein heat-conduction effect is very important.The finite element modeling that damage is formed carries Gross data has been supplied to assess different beta coefficients, and has derived the trend between the acoustic energy of application and lesion depths.It was found that damage Depth and the acoustic energy applied are preferably described by hyperbolic cosine function：

Wherein damage growth parameter α is to start the minimum acoustic energy needed for damage nucleation, and γ is to depend on transducer geometry Shape, frequency and the anatomical Characteristic injury of surrounding tissue are against depth (lesion inversed depth) parameter.

Author determines that about 2mm to the target ablation depth bounds between 9mm may adapt to by anatomical research Ablation energy is transported to arteria carotis barrier film from the conduit being placed in jugular vein.Ground based on above-mentioned theory, laboratory and animal Study carefully, author is it has been proved that in first consistent with equation (3) is approximate, from the ultrasound of the resonant frequency with about 21+/- 2MHz The lesion depths for melting energy acquisition about 1mm of the conduit of transducer conveying ablation energy for every 10 acoustics joule are big.Energy Amount is acoustical power and the product of duration, therefore using the kinds of schemes of control energy transportation parameters ablation can be controlled deep Degree.For example, energy transportation parameters can be selected to optimize multiple variables, such as：The duration is minimized to reduce patient's movement Risk；Utilize wherein lesion width or highly substantially uniform duration-power bracket；For security reason, using pair It it is not the too fast duration to needing the time for adjusting energy delivery to make a response in user or console；Using not being too high And with the power of increased overheat incidence；Use the rational transducer temperature liter for causing to be controlled by coolant flow High power；The duration is minimized to minimize the conduction heating to adjacent tissue；Arrived using allowing to control lesion depths The parameter of about 0.5mm precision.

User can be for example by assessing come free imaging transducer establishment that can be with reference dimension based on ultrasound The image of video determine desired depth of ablation, and on ablation console select desired depth of ablation.Alternatively, The video data that computerized Algorithm can for example be based on ultrasound automatically assesses desired depth of ablation, and will be desired Depth of ablation is communicated to the ablation control algolithm of ablation console.Alternatively, it is all can to assess anatomical features for computerized Algorithm Such as the relative position of internal carotid and external carotid artery and jugular vein and ablation transducer, and to be input to can confirm that or adjust The user for melting the expectation depth of ablation of control algolithm suggests the desired depth of ablation.Ablation control algolithm can use be suitable to Produce and it is expected that the energy transportation parameters of depth of ablation convey ablation energy.

Using computer finite element modeling, author have calculated that multigroup ablation time (for example, energy conveying it is lasting when Between) and apply acoustical power static temperature curve.The theory that the impairment parameter of calculating represents with experimental result and equation (4) becomes Gesture is consistent.Figure 24 A show the result 571 of the finite element modeling of lesion depths and energy.Line 570 is shown to be increased with damage Parameter alpha=3 joule and γ=0.5mm^-1Equation (4) theoretical trend.

The accumulative effect of temperature is derived from the thermal dose of the amount of the energy of deposition, and this is relevant with damage Cambium periodicity. Mainly determined by transducer dimensions, the dimension (such as length and width) of injured side relatively quickly increases and when damage is deep Tranquilization when degree increases slower.In the ablation duration for controlling multigroup power of lesion depths and considering in the time In scope (for example, in the range of about 5 seconds to 25 seconds), it is believed that lesion width and length are substantial constants.2mm depths Damage is considered to have the minimum controllable trauma depth of desired lateral dimension, and the desired lateral dimension is horizontal with transducer It is consistent to size (such as 2mm is wide grow with 4-6mm).For every group of ablation time and power, lesion depths are modeled, created The figure and equation (4) of the relation between lesion depths and the acoustic energy of application are represented, as shown in fig. 24b.

Emulated using the polyacrylamide gel for the data point for producing the lesion depths for multigroup power against time (phantom) confirm the General Theory relation between lesion depths and acoustic energy using laboratory research, the data point by with In producing relation of the lesion depths as the function of energy, the relation is very similar to theory relation.In general, by equation (4) theory relation represented provides to simulation (dotted line 573) and tests the accurate of (circle 574 and solid line 572) both data Fitting.Nucleation energy α=3J and depths of features constant inverse γ=0.5mm is predicted in computer simulation^-1, and experimental data generation is larger α=17J and less γ=0.3mm^-1.The difference of the damage growth parameter(s) of derivation reflects the thermal dose phase assumed in simulation The difference formed for the damage that can be visually detected in polyacrylamide gel.Gel is at a temperature of slightly higher 70 DEG C Become opaque, and the protein denaturation of typical 42 DEG C of beginnings in the biological tissue of the perfusion of the non-zero with assuming in simulation Temperature is compared, and has zero perfusion.Each conduit can have the sound that slightly different ablation transducer conveys to electrical power Should, and can be calibrated using acoustic measurement, to identify the relation of its specific electrical power and total acoustic power.It is deep based on ablation Degree and the calibration of multigroup acoustical power and the relation of time and the electrical power of each conduit to acoustical power, can create each conduit Exclusive dosimetry table, the dosimetry table match desired depth and one group of ablation time and electrical power.

The example of dosimetry table-processing algorithm is shown in Figure 24 C.The algorithm assumes injured depth and the acoustic energy applied Multinomial correlation (polynomial dependence).Acoustical power-ablation time is shown in Figure 24 C left figure 575 The reference contours that the equation (4) of different lesion depths obtains in space.The figure on right side includes the total acoustic power measurement of conduit 576 Value, the control power index derived and ablation time 577, and show the depth residual error (depth of target depth 578 residue).Acoustic power derived from experience-spatio-temporal ablation track is represented by line 579.White diamond 580 shows one Discrete, the specific power of conduit of group and time value.The discrete setting of acoustical power and time control due to generator system Electrical power and ablation time it is limited in one's ability.When the resolving power (resolution) of ablation time is limited to one second interval, sound The discretization of power depends on the specific acoustical power performance of conduit and generator before amplification by the energy of controlling electric energy to 1dB Power.The algorithm is related in conduit specificity, the discretization power of generator and the time value of suitable optimum sound power against time track Among find and the immediate matching of desired depth.Optimum trajectory is defined as the origin at point A and the tangent line at point B Parabola, its midpoint A correspond to more than 2 watts of the minimum acoustical power 5 seconds at, and point B at 25 seconds corresponding to being less than 6 watts Highest acoustical power.The algorithm uses two inputs：First, the general lesion depths acoustic energy dependence value with theory deduction is tested, the Two, dependence value of the conduit specificity acoustical power to generator system control characteristic.The algorithm finds symbol by minimizing function F Close optimal generator power index and the time pair of each desired depth of selected ablation track：

Wherein δ P and δ t are acoustical power deviation and time deviation away from optimum trajectory, and δ d are inclined with optimum depth Difference, α=4, β=1, γ=1 are constants.

The example of the dosimetry table for particular catheter is shown in Figure 25.The first row composition target of dosimetry table Lesion depths, secondary series, which lists, is conveyed to the corresponding electrical power control that the electrical power of transducer is changed by generator system software Index processed, the 3rd row are one group of corresponding ablation times (duration).Other row are listed for verifying and quality control mesh Auxiliary information.Unique ablation dosimetry table can be programmed in memory unit in particular catheter such as In EEPROM.In use, when particular catheter is electrically connected to ablation console, computerized Algorithm in console is from storage Device memory unit reads the unique depth of ablation table of the conduit, and when depth of ablation is selected either automatically or manually, algorithm choosing Corresponding power-ablation time is selected to set and deliver energy to conduit using the setting to produce desired ablation deeply Degree.

Increase ablation size

It is generally related to depth of ablation to melt width.Controllably creating broader ablation can cause deeper to melt.From The ablation energy that the conduit being positioned in vein (for example, jugular vein) conveys and aims at arteria carotis barrier film can have from arteria carotis The depth dimensions that the outside (lateral) of barrier film is orientated to inboard boundary.The depth of ablation can be optimized to cover these borders The distance between, and it can be desirable to avoid ablation from melting the risk of important non-targeted structure beyond inboard boundary to reduce.Profit With the depth of ablation of optimization, depending on the anatomical structure of patient, width can only cover a part for arteria carotis barrier film width.Can It is expected to melt greater percentage of arteria carotis barrier film to increase curative effect.Ablation size (for example, width or height) can pass through It is mobile to melt transducer and optionally move imaging transducer together with ablation transducer and increase, without increasing depth of ablation. For example, the movement of ablation transducer can be realized by following：The side offside deflection (side- of the remote area of ablation catheter To-side deflection), the transducer in rotary guide pipe or conduit, along blood vessel length translational movement conduit or change Can device.Movement can be performed to produce multiple independent ablations or be produced during energy conveys to be extended in bigger volume Raw ablation.Movement can be carried out in imaging, and wherein user can identify the border of desired target area, or ablation can be with By detecting target area boundaries and applying ablation energy only in border come computer control.Border can include for example solving Cut open structure, such as the border of arteria carotis barrier film.The movement of transducer in the catheter can manually be realized by user, or by even The servomotor (servomotor) for being connected to rotatable transducer mounting seat realizes that the servomotor is by computer automatically Control as with required speed and distance, and the feedback signal of such as edge detecting information can be included to identify target area Domain.The alternative of increase ablation size can be to spread or diffraction energy by ablation energy guiding by lens.Lens can To be filled with liquid such as water or salt solution to adjust required diffusion or diffraction.Another alternative solution for producing wider ablation can Including conveying supersonic melting energy from the transducer with convex surface.According to the anatomical structure of patient, user can select for Desired ablation width has the conduit of suitable flexible transducer.Alternatively, conduit can have convex surface transducer and Cover with the hole for being adjustable to custom ablated width.

Bubble eliminates

The embodiment of the anechoic room described herein for including the cooling agent with flowing may be adapted to reduce or eliminate Bubble in cooling agent.Bubble inadvertently may be included in the source of supply of liquid coolant (such as salt solution or water).Pass through Surface tension, bubble may keep being trapped in anechoic room or be formed near ultrasonic transducer or on ultrasonic transducer Energy is formed during conveying.This may have a negative impact to ablation or imaging performance.In the manufacture of conduit, carry surface and live The solution (such as isopropanol) of property agent can cycle through cooling agent transfer passage and anechoic room, and solution can be discharged and lead Pipe is allowed to stand for drying.Surfactant can be retained in fluid contact surfaces so that all surface is all wettable, that is, has drop Low surface tension, be advantageous to remove bubble.

The ultrasonic imaging of radiography enhancing is to check carotid body

This paper any application method can include ultrasonic contrast enhancing imaging, its can improve to carotid body into As ability.For example commercially available Sono Vue of acoustic contrast agent may contain microvesicle.Differential image analysis can be entered by following OK：Using ultrasonic imaging transducer (for example, on imaging catheter or external ultrasound is changed before and after acoustic contrast agent is injected Can be on device) image in photographic subjects region, and movement images are to protrude the tissue of radiography and non-radiography.Contrast agent can pass through note It was shot through sheath and was expelled in the vascular system of patient, sheath there can be the pad around ablation catheter sealing in proximal end Circle sealing, the injection port such as Luer lock with plug valve can be by contrast agent or other injections by the injection port To be deposited on outside the distal end of sheath in the inner chamber for the sheath being expelled in the space around ablation catheter.Area containing contrast agent The domain typically region with blood flow, including carotid body.If the exact position of carotid body can be with imaging technique such as Radiography strengthens ultrasonic imaging, CT or MRI to identify, then target ablation region can focus on carotid body.If unidentified arrive The exact position of carotid body, then target ablation region can include larger region, such as arteria carotis spacer film.

Melt transducer backing

Ablation catheter can include ablation transducer audio insulator or back lining components.Melting transducer can be in multiple directions Upper transmission ultrasonic wave.For example, plate shaped transducer is either substantially flat or bending, can be from the two of transducer Individual face conveys ultrasonic energy.Back lining components can be used for the propagation of shielding ablation energy, therefore ablation energy is only from ablation transducer A face be directed, and back lining components can be additionally used in reduce acoustic losses.

Backing can be sound absorption properties or reflexive.Such as sky that it is at least about 1mm comprising thickness that back member, which can be, The component of the thin layer gas of gas or carbon dioxide.Acoustic insulation body can be for example with least about 0.006 " (e.g., from about 0.008 ") dense material of thickness, such as stainless steel.

The embodiment of acoustic insulation body comprising gas includes the air microballoon in the matrix of embedded such as epoxy resin. When transducer contacts with audio insulator, and the acoustic insulation body phase ratio made of brass or stainless steel, by embedded gas filled microsphere Epoxy resin made of audio insulator can have less mechanical couplings effect.In other words, when transducer be positioned to it is micro- When ball insulator contacts, the vibration of transducer may be suppressed than when its fine and close rigidity with such as stainless steel or brass is exhausted It is significantly smaller when edge body is placed into contact with.Therefore, it is positioned in transducer in the embodiment that is contacted with audio insulator, gas filled microsphere Audio insulator may be more suitable.This design may have such as easily fabricated, a less frangible transducer, and smaller conduit is straight Footpath or before transducer more cooling agent flowing spaces benefit.The combination of microballoon with various diameters can increase absolutely Volume of air in edge body.For example, less microballoon can take up the space between larger microballoon.Audio insulator can have The thickness of (for example, about 250 microns) in about 200 to 300 micrometer ranges, and can include with diameter at about 15 to 25 microns In the range of microballoon (for example, about 20 microns) and with diameter for example in the range of about 180 to 210 microns (for example, about 200 Micron) microballoon combination.

Create the fiducial marker for aiming at artifact

, can be by fiducial marker for the embodiment described herein for including one or more imaging transducers It is positioned in ablation catheter pseudo- to provide differentiable aiming on the video based on ultrasound with imaging ultrasound wave interaction Shadow, aim at position of the artifact identification relative to the conveying direction of ablation energy.Fiducial marker can have for example dramatically different In the acoustic characteristic of surrounding tissue, so echo is bigger (high echo) or smaller (low echo) than surrounding tissue.Fiducial marker Material or surface relative to the surrounding tissue being imaged can be sound wave high reflection or high-selenium corn.Be imaged around group Knit and compare, fiducial marker there can be more consistent echo.Fiducial marker can be positioned on the video based on ultrasound Indicate the opposite direction of ablation energy conveying.In the configuration, the image (for example, shade) for aiming at artifact will not interfere with target area Domain and the image of surrounding tissue.The image of aiming artifact on video based on ultrasound can be differentiable shape, such as wedge Shape or the black sent in one direction from the center of the video based on ultrasound or the lines of white, and user is appreciated that to disappear Melt energy and aim at opposite direction.

It is contemplated that other relative directions or arrangement of fiducial marker.Disappear for example, two fiducial markers can be located at Melt on the either side of transducer, to indicate that ablation energy is conveyed between artifact is aimed at caused by two.Alternatively, it is two thin Fiducial marker can be positioned in close, should to produce the image for being similar to two bright wisp bands by a narrow strips Image is probably more accurate and detectable aiming artifact.Or as long as understand taking aim at for fiducial marker and ablation energy The relative position in quasi- direction, fiducial marker can be placed on to the other positions of the circumference around conduit.

Compared with the typical organization in target area, fiducial marker can include with imaging ultrasound wave interaction, with Absorbed with the differentiable mode of typical organization in target area or the material of reflectance ultrasound ripple.For example, the material can be caused Close material, such as stainless steel or the pneumatic element for suppressing transonic.In some embodiments, fiducial marker can be also The component of back lining materials as ablation transducer, the back lining materials also suppress the conveying of ablation energy.In other embodiments In, fiducial marker can be single part, or can provide other functions, such as distal component, guidewire lumen or The structural support of echoless Housign support.

One embodiment of fiducial marker is included with containing receiving gas filled microsphere tube chamber in air or epoxy resin Stainless steel hypotube.Hypotube can accommodate air or microballoon in both ends adhesive seal.Hypotube can have for example About 0.028 " to 0.038 " external diameter.

The another embodiment of fiducial marker includes line such as round wire (for example, with about 0.028 " to 0.038 " Diameter), or flat belt-like line (for example, with about 0.005 " multiply 0.030 " section).Line can be stainless steel.Optionally Ground, line can be sealed by the part further to be interacted with ultrasonic imaging ripple, for example, wire coil can be wound online On, or line can be coated in the epoxy resin of the microballoon containing air.

Fiducial marker can have the increased echogenicity compared with surrounding tissue, to increase its specific characteristic.Example Such as, fiducial marker can include the rough surface of reflectivity for improving ultrasonic wave or the groove of linearity pattern or have texture Surface.When imaging transducer is not parallel to reference mark, this can be particularly useful.Some IVUS conduits include and conduit The transducer that is positioned into minute angle of axis.Although angle can be with very little, it can make wave reflection go out fiducial mark with incidence angle Note, reduce the ability of transducer capture echo.

Fiducial marker can include the piezoelectric element vibrated when applying high frequency electric, and transmitting can be examined by imaging transducer The acoustical signal of survey is to provide the robust image of fiducial marker.

Image enhaucament

The system of tissue for being imaged to target area and in ablation targets region can provide digital video or Video based on the video of ultrasound, the digital video or based on ultrasound is reflected tissue from what ultrasonic imaging transducer was launched And the ultrasonic signal received by imaging transducer produces.Figure 30 illustrates be placed in the jugular vein near carotid bifuracation IVUS conduits caused by based on ultrasound video frame example.

Can be aided in by vision, animation or message further enhance the video based on ultrasound, so that provide a user can It can help to understand the video based on ultrasound, planning or the information for carrying out carotid body ablation procedure.

The embodiment for being used to be imaged and melt the system of carotid body with image enhaucament can include conduit, described Conduit has ultrasonic imaging transducer and ablating device；Melt console；Ultrasonic imaging console, the ultrasonic imaging console With for sending signals to imaging transducer and the device from imaging transducer reception signal；The calculation performed with computer Method, it is from the signal creation that imaging transducer receives based on ultrasonic video；Image enhancing unit, it utilizes the figure for creating enhancing Video of the computerized algorithm processing based on ultrasound of picture；And the display of the image of display enhancing.Figure 27 illustrates be The schematic diagram of system.Image enhancing unit hardware can include image or frame grabber, RAM, CPU, memory such as hard drive Device and graphics card.Imaging control console can (a) ultrasonic imaging signal is sent to imaging transducer 435, (b) receives from transducer Vision signal based on ultrasound is sent to image enhancing unit by echo signal, and (c).Ablation console can (d) will disappear Melt energy and be sent to ablation 436 (for example, supersonic melting transducer), (e) is from such as TEMP of the sensor in conduit Device receives feedback, and (f) sends information (for example, ablation state, energy transportation parameters, user interface control, will be shown in display Information on device) arrive image enhancing unit, and (g) from image enhancing unit receive information (for example, to control ablation state, To control energy transportation parameters).Image enhancing unit can send the video to display with (h).

Conduit can be an embodiment of ablation catheter described herein, the ablation catheter be configured to accommodate ultrasound into Integrated as conduit or with imaging transducer, and can also include aiming at artifact to identify the ablation energy on the video based on ultrasound The direction of transfer of amount.Ablating device can include supersonic melting transducer or through vascular wall so that RF energy or chemical agent is defeated Deliver to other ablation energy conveying device such as pins of ablation targets tissue.The system can also include being adapted to ablating device for example The ablation energy console of ultrasonic generator or RF generators.

Imaging transducer or transducer can be (for example, supersonic melting transducer, RF pins, use for example positioned at ablation Pin, RF electrodes, generating laser in injected chemical medicament) neighbouring ablation catheter remote area or piezoelectricity or electricity thereon Hold transducer.Imaging transducer can by the space around the distal region of Acoustic Wave Propagation to conduit, and receive in the space from The echo of Tissue reflectance.

Ultrasonic imaging console, which can produce electric signal and control, is converted into the signal of sound wave to the biography of imaging transducer Send.The echo received by imaging transducer can be converted into electric signal, and the signal is transferred back to imaging control console.Some realities The scheme of applying can use single transmitter and receiver component or console.In some embodiments, imaging transducer can To be positioned at IVUS conduits (for example, Volcano Corporation0.035 conduit or Boston Scientific Ultra Conduit) on, and ultrasonic imaging console can be the system compatible with IVUS conduits. Can be separately provided IVUS conduits and compatible imaging control console with system, system can be configured as accommodating the IVUS conduits and Imaging control console.In another embodiment, imaging transducer can be integrated in ablation catheter, and imaging control console can be with Ablation energy console is separated or is desirably integrated into individual unit, and can be with both imaging transducer and imaging control console A part as system.

Produced by shock transducer echo and passed back to the electric signal of imaging control console can be displayed in available for establishment it is aobvious Show the image or video (video i.e. based on ultrasound) on device.For example, the algorithm process and defeated that signal can be performed by computer Go out to the display or video-out port on ultrasonic imaging console.

Image-capture hardware for capture images or video is known in the art, and can be regarded by capture single frames Frequently, the hardware interface for the analogue value being converted into numeral and result being fed to computer forms.For example, Image grabber can connect The video-out port being connected on ultrasonic imaging console, and the numeral of video being explained to, being sent to image enhaucament calculates Machine, image enhaucament computer can be incorporated to supersonic melting console either single unit.

Image enhaucament computer can run the algorithm for strengthening video.The algorithm can handle each video in real time Frame, the frame of video use the orientation of the reference mark or aiming artifact tracking ablation catheter in image.The algorithm can pass through Find and or not any unique mark of shape when being orientated and changing to identify aiming artifact.Input to algorithm can be by base Video, ablation console (for example, console state, energy feed status, depth parameter) or user interface (example in ultrasound Such as, the identification of anatomical features, setting, scaling, translation, contrast, the feature to be shown) provide.Output can be to display (for example, the image of enhancing, the original video based on ultrasound, the image for the enhancing being superimposed upon on the video based on ultrasound) or to disappearing Melt console (for example, the signal of control energy conveying, signal of control energy transportation parameters such as power and time).

In addition to the video of capture, user can control the input to algorithm.For example, user can select desired disappear Melt depth or identify a part for anatomical structure, such as internal carotid or internal carotid.User input can by can comprising On the unit (for example, ablation console) of image enhaucament computer user interface (for example, knob, driver plate, touch-screen, mouse, Voice command) control.Before ablation energy is conveyed, user can adjust depth of ablation on ablation console, for example, such as The superimposed image of the ablation of fruit estimation presents long and extends beyond the border of arteria carotis barrier film, or too short without filling Divide ground filling arteria carotis barrier film, and the superimposed image for the ablation estimated can reflect the depth of adjustment.It is super in ablation In the embodiment of sound ablation transducer, depth of ablation can be by automatically adjusting the parameter such as power and time of given frequency To control.

Algorithm for image enhancement can output signals to monitor.For example, if algorithm is physically included in ablation control On computer in platform, output can be to output port (for example, VGA, SVIDEO, DVI, HDMI port) or outer to being connected to The cable of portion's monitor melts the display on console to connection.External display can provide together with system, or A part as catheterization lab equipment is provided separately.Except the video of imaging importing with enhancing based on ultrasound it Outside, monitor can also show other information such as fluorescopy or X ray, patient information or physiological parameter.

The black and white version of the embodiment of the frame of video of enhancing is shown in Figure 28 to 31.The algorithm can identify that imaging is led The expection image (image generally can be the black circles 440 of picture centre) of pipe and aim at artifact (its generally can be from Uniqueness (for example, black or white) wedge 441 of image center location radiation.Such as sent out by fiducial marker or synchronous aim at Artifact is aimed at caused by emitter single imaging catheter is inserted into the embodiment in the IVUS chambers of ablation catheter can be with It is particularly useful.Alternatively, the embodiment integrated for wherein imaging transducer and ablation catheter, can be by reference mark Device, synchronous aiming transmitter are produced by omitting imaging transducer on the relative direction in the sighted direction with ablation energy It is raw to aim at artifact, or replace with aiming at artifact, sighted direction may be programmed into imaging algorithm and be shown in based on ultrasound Video on.User can use fluoroscopy imaging guiding that the conduit containing imaging transducer is transported through into vascular system and arrive Close to the region of carotid bifuracation.In the example shown in Figure 28 to Figure 31, conduit is transported to arteria carotis point by intravenous route Region near fork.Can be that anatomical structure is expected based on conduit carrying method by arithmetic programming.In the example shown, calculate Method it is contemplated that the black round-shaped 442 in the picture around the imaging catheter of the heart is jugular vein 12, and about 3 to Two black circles 443 and 444 in region in 8mm size range are probably arteria carotis.If imaging system can be right Other anatomical features such as carotid body or carotid nerve or non-targeted neuroimaging, then they can also be identified. As illustrated, the image of enhancing can include the image of the superposition on the video based on ultrasound, such as arteria carotis is (for example, neck is total Artery, internal carotid 445, external carotid artery 446) profile, the profile 447 of ablation catheter, indicate the direction of transfer of ablation energy Ablation towards or will convey ablation energy direction arrow 448.In the embodiment illustrated, ablation can To be supersonic melting transducer, and the image strengthened includes the estimation damage width that instruction projects on ablation energy conveying direction The line 449 of degree.The estimation ablation site 450 that the image of enhancing also includes in the position that expected estimation ablation site 450 is created Profile.If the ablation profile 450 of estimation is located in inappropriate region (if for example, it is not or not the side of arteria carotis barrier film In boundary, if it contacts or be too close to arteria carotis, or if it is in the position previously melted), it can be distinguished Know (for example, red, to be shown in Figure 31 with dotted outline).If the ablation profile of estimation is positioned at preferably generation ablation Position, such as between arteria carotis in arteria carotis spacer film, it can be identified (for example, green, such as the dotting wheel in Figure 28 Shown in exterior feature 450).

In order to confirm the identification of internal carotid and internal carotid, it may may require that user slides conduit disengaging at leisure Several centimetres, this may create two arteria carotis with conduit is pulled out and converge at arteria carotis communis and as conduit is pushed into and It is branched into the video of internal carotid and external carotid artery.

As shown in figure 30, when ablation energy is transmitted, the image of enhancing can show animation to indicate that energy conveys, example Such as the colourama (line 452 is shown as in Figure 30) of bounce.Animation of the instruction through the time course of ablation duration can be shown, Such as the color-bar of growth can fill the ablation profile of estimation (figure 30 illustrates for line 453), be indicated without profile Time=0s and integrity profile instruction complete duration.

After ablation has been produced, the image of the ablation 453 for arteria carotis, such as the face with uniqueness can be shown Color for example white, the ablation and ongoing second ablation that its display is completed as shown in figure 33.

The information calculated by algorithm for image enhancement can feed back to energy conveying console.If convey the phase in ablation energy Between exist and unintentionally move, then the image algorithm strengthened can send signal to suspend or interrupt ablation energy to ablation console Conveying, and the ablation profile that the image strengthened can be filled with such as red color display portion may not have with instruction There are the right times for reaching and producing desired depth of ablation, and user can select to carry out another ablation in same position.

If conduit pushes or pulls on back forward, algorithm for image enhancement can use the distance between internal carotid and external carotid artery Change calculate translational movement.

Information from other imaging sources such as fluoroscopy, MRI, CT or the second ultrasonic imaging transducer can input Into algorithm for image enhancement, and it can be used for the image for creating the position of carotid body or nerve, to calculate angle of forking, with wound 3D rendering is built, or to calculate the height of the ultrasonic imaging plane higher than carotid bifuracation.

Using another standard the distance away from carotid bifuracation can be identified (for example, leading to carotid bifuracation more Distance on favourable direction).For example, fiducial marker can be the slidable line of interior intracavitary in conduit.Line standard can To be marked with the differentiable echo that can be alignd with carotid bifuracation.When conduit is pushed into, line standard can be kept In position.Line standard can have away from first mark preset distance (such as away from first mark about 6mm) place it is another Individual diacritic mark.When conduit is pushed into when seeing the second mark, it is possible to understand that imaging plane is apart from the pre- spacing of bifurcated From (such as 6mm).Line standard can have multiple marks (for example, per 2mm) of instruction increment.Line standard can also have Radiopaque mark, it can show in fluoroscopy.

Algorithm can be with the rotation of control figure picture so that can for example show the image of enhancing, wherein sighted direction always to On.

Algorithm for image enhancement can use known dimensions such as conduit diameter or aim at artifact width as scale, and And the distance between anatomical features are calculated, for example, jugular vein, arteria carotis barrier film, internal carotid, external carotid artery, arteria carotis barrier film The relative position on border, artery diameter, the change of artery diameter, the change of the relative position of anatomical features, the ablation of estimation or The size and relative position of caused ablation.The distance of calculating may be displayed on the superimposed image of enhancing, for example, as row Table or label.Algorithm can be provided the user based on the distance of calculating instruction or suggest, for example, how to reverse or deflectable catheter with The blood vessel (for example, jugular vein) of receiving conduit is manipulated, reverses the how many distances of conduit and where to disappear to torsion conduit to adjust Melt the aiming of element, on depth of ablation or influence depth of ablation parameter adjustment, how by conduit into and out blood vessel with Realize suitable position.

Algorithm for image enhancement can be to ablation console input information.For example, the measurement calculated by algorithm for image enhancement Value and relative position can be used for adjust automatically parameter (for example, power and time) to control depth of ablation, so as to disappearing for estimation Melt size in the space most preferably between the inner side and outer side border of arteria carotis barrier film and fill the space.Algorithm for image enhancement The apparent motion during ablation can be detected, it can send signal to suspend or terminate the defeated of ablation energy to ablation console Send.It can be melted with weave mode, wherein ablation energy melts transducer to swing in mobile target such as rotary ultrasonic Transmitted through arteria carotis barrier film from an arteria carotis to while another arteria carotis.Algorithm for image enhancement can indicate to the user that When move or how fast movement aims at, and when substantial amounts of energy is sent to position, ablation console can be transmitted Number with suspend energy conveying, then continue when algorithm for image enhancement, which detects, is moved to appropriate location convey energy.Alternatively, The movement that ablation aims at can be controlled by mechanism such as servomotor, and the mechanism passes through measured value and phase based on calculating To position to the input control from algorithm for image enhancement.

Mobile detection

Ablation energy, particularly supersonic melting energy can be less than about 30 seconds (for example, less than about 25 by the transmission duration Second, less than about between 20 seconds, about 7 to 23 seconds).When ablation energy is transmitted, the sighted direction of ablation energy may be inadvertently Moved from desired target direction.This can cause to produce ineffective ablation in desired destination organization or damage non-target tissues Risk.Disclose some methods for mitigating these risks.

Orientation ablation energy can be moved for example by patient from the movement of destination organization (for example, moving-head, cough, beating Sneeze, shrink back caused by it is unexpected or slowly moving) or the movement of the part for being connected to conduit of conduit or patient-external draw Rise.

Detection orientation ablation energy can include following from the possibility movement of destination organization：By user manually or automatically The movement of patient body or head is monitored using the sensor of picture charge pattern or such as accelerometer；Imaging algorithm can be programmed Or algorithm for image enhancement identifies for the important movement of increase risk；Can be by such as accelerometer or multiple accelerometers Sensor is placed in all ablation catheters of ablation catheter as disclosed herein；Can be using for example being examined using magnetic field or electric field The 3D orientations for surveying the magnetic coil being positioned in ablation catheter or electrode follow the trail of the device of patient's body with tracing system.

Reducing mobile risk may include following methods：If detecting movement, user can manually cut off energy conveying； It can require that actuator is maintained at on-position to convey energy and can be by discharging actuator and rapidly right by user Movement is made a response；Automatic patient, which moves detection, can be input to energy conveying console to stop or adjust energy conveying；Inspection Console can be conveyed to energy and send signal by surveying the imaging significantly moved or algorithm for image enhancement, it is stopped or adjust energy Conveying.

When stopping or adjusting energy conveying, energy conveying console can be shown to user due to potential mobile risk And the message for cutting off the conveying of energy.The message can the number of further show process be done.

Ultrasonic image-guided interstitial ablation needle

Many embodiments disclosed herein include high energy ultrasonic as ablation energy.Blood vessel with imaging capability The alternate embodiment of inner catheter can include mesh of the ablation energy of other forms with ablation vessels (such as jugular vein) nearby Mark tissue (for example, tissue in arteria carotis barrier film).Ultrasonic image-guided pin type ablation catheter (ablation catheter) can combine For detecting target (for example, arteria carotis barrier film, carotid body) and the intravascular ultrasound imaging transducing by ablation needle target goal Device.Ablation needle can transmit ablation agent or other ablation energies, such as radio frequency or cooled RF.As shown in figure 32, ultrasonic imaging The interstitial ablation needle catheter 460 of guiding can include ultrasonic imaging transducer and extensible pin.Imaging transducer 461 can be with On single conduit (for example, IVUS conduits), it is advanced to the distal region of ablation catheter by the inner chamber 462 in ablation catheter Domain.Imaging transducer can be located in optional anechoic room 463, and anechoic room 463 includes the fiducial marker for aiming at 464, fiducial marker 464 reflects or absorbed ultrasonic wave, to produce differentiable artifact on the video based on ultrasound, the artifact Represent the relative direction that extensible pin 465 will be pushed into.Extensible pin can have tip 466 to pass through vascular wall to promote (for example, jugular vein 12).As illustrated, blunting probe 467 can be released from sharp syringe needle with through destination organization.Blunt nosed spy Pin can pass through such as fatty tissue in target area, and reduce and puncture artery (such as arteria carotis) or damage non-targeted The risk of nerve.Probe 467 can be configured as conveying ablation energy.For example, it can include RF electrodes 468, the RF of cooling Electrode or the inner chamber for conveying ablation agent.Probe can include such as temperature sensor of sensor 469 (such as thermocouple), with Monitoring or control energy conveying.Extensible prong or probe can have echo coating to improve ultrasonic imaging.Conduit can be with It is deflectable or is conveyed by deflectable sheath to help to position or manipulate vein to obtain suitable ablation locations.Double Multiple pins can be disposed for example to produce larger ablation by transmitting radio frequency in the configuration of pole.Carotid body stimulant (such as Adenosine) target area can be transported to by injecting inner chamber 470 or extensible pin or probe before and after ablation, with true Recognize whether carotid body has inactivated.

As shown in figure 33, the alternate embodiment of ultrasonic image-guided pin type ablation catheter 471 can include and ablation The integrated imaging transducer 472 of conduit.Compared with the embodiment shown in Figure 32, the embodiment can have narrower diameter (such as in the range of about 8 to 10FR, about 9FR), and lack IVUS chambers and provide more spaces for needle cavity 473.One group of collection Into imaging transducer 472 can allow pin deploy relative direction be programmed into based on ultrasound video generation software in, from And can based on ultrasound video on indicator expansion direction.Alternatively, the integrated imaging transducer of the group can include Gap or fiducial marker in transducer spacing, to produce identification relative to the cognizable of the relative direction of pin expansion direction Image.

Ablation catheter with integrated imaging transducer

The embodiment that Figure 34,35 and 36 show ablation catheter, it is included positioned at the integrated of ablation transducer distal side Imaging transducer.These embodiments can lead to the sheath that turns to that sheath is crossed such as shown in Figure 25 A to 25C and be transported to close to mesh In the vein (for example, jugular vein) for marking arteria carotis barrier film.Sheath can be turned to and can be used for manipulating vein relative to target arteria carotis The position of barrier film, or help to position and aim at ablation transducer.These embodiments can be with the straight of about 8.5FR to 9FR Footpath.

Figure 34 shows the distal component 480 of ultrasound catheter, and it is (such as described herein that it includes being installed to back lining materials 482 Those) ablation transducer 481, back lining materials 482 are installed to manifold 483.Manifold is machined into including cavity 484, it combines with thin polymer housing 485 (e.g., from about 0.0008 " thick PET) and defines anechoic room.Polymer shell surrounds nothing Echo studio and manifold is sealed to airtightly to seal the room.Cooling agent can be defeated by the cooling agent conveyor chamber in conduit sheath Anechoic room is sent to, it leaves inner chamber from cooling agent delivery port 487 there.Conduit is constructed such that cooling agent changes in ablation Can be on device by keep suitable transducer temperature, therefore it will not be overheated.Overheat may damage transducer, conduit or blood Tubing, or cause blood clotting.Cooling agent can leave chamber, coolant outlet port via cooling agent discharge port 486 486 are in fluid communication with fluid discharge chamber 488, and fluid discharge chamber 488 makes cooling agent release into patient along conduit sheath transmission In vitro.Conduit can optionally be configured to transmit on seal wire 489, by along sheath and the guidewire lumen of manifold 490.Conduit bag Include a series of imaging transducers 491.As shown in Figure 34 cross section B-B, imaging transducer can surround the circumferential registration of conduit, Except position 492 opposite with melting the sighted direction 493 of transducer on circumference.Base caused by the imaging transducer serial from this The artifact of the transducer from the missing can be shown in the video of ultrasound, it provides the finger of the sighted direction of ablation transducer Show.Alternatively, imaging transducer can surround the whole circumference positioning of conduit, stop that the imaging artefacts of imaging ultrasound can be determined Position for example with the opposite direction of sighted direction for melting transducer, with the video based on ultrasound identification melt transducer Sighted direction.Alternatively, ablation transducer may be programmed into generation base relative to a series of sighted direction of imaging transducers In the software of the video of ultrasound, so as to indicate sighted direction on the video based on ultrasound.

Embodiment shown in Figure 35 includes the fluid filling sacculus 495 around ablation transducer 496, with accommodate such as without The flowing cooling agent of bacterium water or salt solution.Sacculus can be conveyed with non-unfolded state in sheath, and worked as and pushed away from sheath When going out, cooling agent the cavity in sacculus can be transported to by cooling agent Delivery lumen with increase pressure and by sacculus be deployed into as There is increased diameter deployed condition shown in figure.Deployed condition can allow bigger coolant volume to surround ablation transducing Device, or ablation transducer can be allowed bigger than the transducer of embodiment shown in Figure 34.

Embodiment shown in Figure 36 includes the small perforation from chamber seepage with permission cooling agent (such as salt solution) 502 501 leakage polymeric shells 500.Leakage housing can prevent blood heat up or be agglomerated to treatment ultrasonic energy be passed Conduit.

Embodiment shown in Figure 35 and 36 can optionally include other features of Figure 34 descriptions, such as conduit cavity With the device of the sighted direction for indicating ablation transducer.

Embodiment shown in Figure 38 includes ablation transducer 585, and it, which is oriented to mainly laterally launch from conduit, disappears Melt ultrasonic energy.The distal end of ablation transducer is mounted to the rotation imaging transducer 587 of drive shaft 588, and drive shaft 588 can To reach the near-end of conduit by conduit sheath, rotated in the proximal end drive shaft 588 by motor.Fiducial marker 589 can be with In the visual field of imaging transducer, there is provided relative to the relative direction of the sighted direction 586 of ablation transducer.Rotary-type imaging Transducer can produce the image or video based on ultrasonic wave of almost plane, and the plane transverse is away from (for example, away from about 2mm, away between about 1mm and 3mm, away from being less than about 4mm) melt the conduit of transducer.Fiducial marker can be stainless steel Other embodiments of band or fiducial marker as described herein.

Alternate embodiment can have the imaging transducer positioned at ablation transducer near-end, or positioned at ablation transducer Imaging transducer proximally and distally.

Transmitting from ablation transducer is imaged

Substitute or except integrate fiducial marker with based on ultrasound video on produce aim at artifact in addition to, it is intravascular into Picture and ablation system can be configurable to generate since the image of the signal generation ultrasonic echo of ablation transducer conveying, to carry For the accurate instruction of the sighted direction to melting transducer.Ablation transducer can produce the ultrasound letter synchronous with imaging transducer Number, and imaging transducer can be with detection signal.These ultrasonic signals not necessarily play a part of ablation tissue, but mainly rise The effect to be communicated with imaging transducer.However, ultrasonic signal will be sent from catheter ablation transducer, and with supersonic melting signal The direction identical direction propagated during ablation is traveled in tissue.For example, because ablation transducer can have about 20MHz Resonant frequency, and imaging transducer can have about 9MHz resonant frequency.Imaging pulse (for example, be with frequency 9MHz electric current) imaging transducer can be sent to from console, imaging transducer vibration sends ultrasonic waves into surrounding tissue In.As shown in Figure 37 A, the echo of the imaging ripple from the tissue that rebounds out returns to imaging transducer, to be detected by imaging system With the video based on ultrasound for being converted into showing surrounding tissue.Ablation transducer can sense and beam back synchronous imaging pulse, or Directly activated by amplifying identical imaging pulse.For example, system control position can be to imaging transducer and ablation transducer two Person sends synchronous signal to be imaged to the sighted direction 503 for melting transducer, and desired mesh is aimed to help to melt transducer Mark 504.Although ablation transducer has higher resonant frequency, it has proved that has when 9MHz imaging pulse is sent to During the transducer assemblies of 20MHz resonant frequencies, transducer has enough bandwidth and sensitivity, and this causes in the range of 9MHz Ablation transducer transmitting is enough can be detected by imaging transducer and can cause the ultrasound of image enhaucament.These aim at transmitting with The direction identical direction conveyed is transported to tissue with ablation ultrasound emission.Exposed to the production of the region for the tissue for aiming at transmitting Raw extra echo, the extra echo are detected by imaging transducer and in regarding based on ultrasonic wave as illustrated in figure 37b It is illustrated as the enhancing echo area of the sector or wedge 505 highlighted on frequency.It is alternatively possible to introduce or change supply into As the arbitrary phase delay between the imaging signal of transducer energy and the imaging signal of supply treatment transducer energy, cause to come Helpful destructive interference between from the reflective echo of ultrasonic imaging signal and treatment signal.For example, the phase delay of 180 degree Destructive interference can be produced between being imaged and melting transducer echo and cause the echo of reduction on the video based on ultrasound The region of reflection, similar to shown in Figure 37 C, wherein sighted direction will be more darker than the image of surrounding.User can be disappeared by manipulating Melt conduit or delivery sheath to adjust the sighted direction of ablation transducer, until the video based on ultrasound shows satisfactorily court Aiming transmitting to destination organization (for example, arteria carotis barrier film).

Treatment method：

Ablation energy source for such as high-frequency current generator of therapeutic ultrasound can be located at the outside of patient.Occur Device can include computer control unit either automatically or manually to adjust the frequency and intensity for the energy for being applied in conduit, apply The opportunity and period of energy, and apply the security limit of energy.It should be appreciated that energy delivery electrodes described herein Embodiment can be electrically connected to generator, even if generator is not clearly shown or described by each embodiment.

Ultrasonic visualization can be included by being configured to aim at ultrasonic energy the ultrasound ablation conduit of arteria carotis barrier film Ability.Ultrasonic visualization can include Doppler with to blood flow imaging.Doppler can be used in external carotid artery internal rotation conduit, To determine when that conduit aims at internal carotid through arteria carotis barrier film.Supersonic melting can towards internal carotid laying for direction simultaneously It is deposited in target arteria carotis barrier film.

Can be by applying the ablation energy from the neighbouring ablation in the distal end of carotid body ablating device in neck At artery body or neighbouring carotid body produces the tissue damage of ablation.The tissue damage of ablation can make carotid body disability or can To suppress the activity of carotid body or interrupt conduction of the afferent nerve signals from carotid body to stomodaeal nervous system.Carotid body Disability or suppress to reduce the response of change that blood vessel glomus cell forms blood gas and efficiently reduce incoming neck to move The activity of arteries and veins somatic nerves or the chemoreceptor reflex of patient obtain.

Include being based at least partially on according to the method for a specific embodiment and confirm that patient has sympathetic nerve Jie The disease led melts at least one carotid body of patient, the sympathetic nerve mediation it is disease such as heart, metabolism Or the disease of lung, such as hypertension, insulin resistance, diabetes, pulmonary hypertension, resistance to the action of a drug hypertension (such as intractable height Blood pressure), congestive heart failure (CHF) or for heart failure or the expiratory dyspnea of the disease reason of lung.

Program can include diagnosing, the selection based on diagnosis, further screen (such as the baseline of chemosensitivity is commented Estimate), it is based at least partially on diagnosis or further screens via chemocepter (such as carotid body) ablation procedure for example One in disclosed embodiment treats patient.In addition, after the ablation, the method for the treatment of can include being melted Assess afterwards with (such as the adjustment of medicinal treatment, in new position of being made decision compared with baseline estimate and based on the assessment Or different parameter re-treatments is used, or if only having melted a chemocepter before, melt the second chemoreception Device).

Carotid body ablation procedure can comprise the following steps or its combination：Patient is calm, positions target peripheral chemical Receptor, visualization target peripheral chemoreceptor (such as carotid body), it is peripheral chemical impression to confirm target ablation position Device is in close proximity to peripheral chemoreceptor, confirms target ablation position safely away from preferably protected important structure (such as hypoglossal nerve, sympathetic nerve and vagus nerve), before, during or after ablation steps stimulate (such as electricity, machine It is tool, chemical) offer to target site or target peripheral chemoreceptor, monitors the physiological responses to the stimulation, disappearing The forward direction target site for melting step provides temporary transient nerve block, monitors the physiological responses to the temporary transient nerve block, fiber crops Liquor-saturated target site, brain is protected not moved by potential embolism, Thermal protection artery or wall of vein (such as arteria carotis, jugular vein) or neck The interior side direction of arteries and veins spacer film or important neuromechanism, ablation targets position or peripheral chemoreceptor, monitor ablation parameter (such as blood flow in temperature, pressure, duration, arteria carotis), physiological responses also, if dangerous are monitored during ablation Or undesired physiological responses occur before collateral neurotrosis turns into permanent, stop melting, during ablation steps Or the reduction of chemocepter movable (such as chemosensitivity, HR, blood pressure, ventilation, sympathetic nerve activity) is confirmed afterwards, remove Ablating device, assessed after being melted, chemocepter ablation procedure is repeated to another peripheral chemoreceptor in patient Any step.

Physiology test or the collection of information can be included by being assessed after patient screening and ablation, for example, chemocepter is anti- Penetrate sensitivity, central sympathetic activity, heart rate, HRV, blood pressure, ventilation, the generation of hormone, peripheral vascular resistance, Blood pH, blood PCO₂, the degree of hyperventilation, peak value VO₂、VE/VCO₂Slope.Be measured directly maximal oxygen uptake ( It is more correctly pVO in heart failure patient₂) and the effciency of respiratory index VE/VCO₂Slope has been shown as being heart failure The reproducible mark of middle exercise tolerance and provide objectively and other on the clinical state of patient and the information of prognosis.

Treatment method can carry out electro photoluminescence to confirm close to carotid body including the use of stimulating electrode to target area.Example Such as, produce positive carotid body stimulating effect has under about 20 to the microseconds of 40Hz and 50 to 500 (μ s) pulse duration The stimulus signal for having 1-10 milliamperes (mA) train of pulse can indicate, stimulating electrode is sufficiently closing to carotid body or carotid body Effectively to be melted to it in the scope of nerve.Positive carotid body stimulating effect can be the increase of application simultaneously with stimulation Blood pressure, heart rate or ventilation.These variables can be monitored, record or show to be confirmed close to carotid body with helping to assess.Example Such as, the technology based on conduit can have the stimulating electrode for being in close proximity to the ablation for ablation.Selectively, ablation Itself can be used also as stimulating electrode.Selectively, the energy delivery element of the ablation energy of non-electrical form is conveyed, for example, it is low Temperature ablation applicator, can be configured as also conveying electrical stimulation signal described above.Another selectable embodiment party again Case includes the stimulating electrode different from ablation.For example, stimulation probe can be made sudden and violent with by performing the operation between surgery average of operation periods The doubtful carotid body contact of dew.Positive carotid body stimulating effect can confirm that structure under a cloud be carotid body and Ablation can start.Physiological monitor (such as heart rate monitor, blood pressure monitor, blood flow monitor, MSNA monitors) It can be communicated with the stimulus generator (it can also be ablation generator) of computerization to provide the feedback letter in response to stimulation Breath.If physiological responses are related to the stimulation provided, then the generator of computerization can provide the instruction of positive confirmation.

Alternatively or additionally, the medicine of the known chemosensitive cell for exciting carotid body can be injected directly Enter in arteria carotis or whole body be administered in patient's vein or artery to trigger hemodynamic or breathing response.It can excite The example of the medicine of chemocepter includes nicotine, atropine, doxapram, almitrine, hyperkalemia, theophylline, adenosine, sulphur Compound, lobeline, acetylcholine, ammonium chloride, methylamine, potassium chloride, anabasine, coniine, cytimidine, acetaldehyde, l- MeChs Acetyl base ester and ethylether (acetyl ester and the ethyl ether of 1-methylcholine), amber Phatidylcholine, piperidines, same-iso- muscarine and single phenolic ester of acetylsalicyclic acid amides, the alkaloid of Veratrum, sodium citrate, three phosphorus Adenosine monophosphate, dinitrophenol, caffeine, theobromine, ethanol, ether (ether), chloroform, phenyldiguanide (phenyldiguanide), sparteine, Coraminum (nikethamidum), cardiazol (pentylenetetrazole), dimethylamino methylene two The Methyl iodide (iodomethylate of dimethylaminomethylenedioxypropane) of epoxide propane, second Base trimethyl ammonium propane (ethyltrimethylammoniumpropane), trimethyl ammonium, hydroxytryptamine, papaverine, it is new this It is bright, acid.

The method of description can include the medicine delivery of the Ultrasound-activated to arteria carotis complex.Medicine can be impregnated in energy In the particle of enough Ultrasound-activateds.Microvesicle, nano particle, liposome comprising such pharmaceutical composition and encapsulating are in the polymer The intravenous or direct intra-tumoral injection of bioactivator undergoes physical change when being subjected to ultrasonic beam.Composition includes micro emulsion Liquid, it can produce microvesicle as cavitation nucleus in injection process, and strengthen the conveying of the Intracellular drug in arteria carotis complex. Supersonic beam is administered to and can be discharged into the arteria carotis complex of the drug infusion of encapsulating with stimulation therapy agent by applications of ultrasound shadow Loud selected volume.In addition to the release of therapeutic agent, microvesicle can be to ultrasound caused by original position during ultrasonic irradiation program Imaging produces to be instructed in addition.

Treatment method be additionally may included in after ablation electricity or chemical stimulation put on target area or capapie Apply, to confirm successfully ablation.Heart rate, blood pressure or the change of ventilation can be monitored or by heart rate, blood pressure or ventilation with disappearing The reaction of stimulation is compared to assess whether the carotid body of targeting is ablated to before melting.After ablation stimulate can use be used for into The same equipment stimulated before row ablation is carried out.Physiological monitor (such as heart rate monitor, blood pressure monitor, blood flow monitor, MSNA monitors) it can be communicated with the stimulus generator (it can be also ablation generator) of computerization to provide in response to thorn Sharp feedback information.If compared with the physiological responses before ablation, physiological responses related to given stimulation after the ablation Reduce, then the generator of computerization can provide instruction ablation effect or possible program suggestion, such as repeat ablation, adjust Whole ablation parameter, change position, melt another carotid body or chemical sensor or terminator program.

Device described herein can also be used by electric nerve retardance come temporarily hit unconsciously or block nerves conduction.Temporarily When nerve block can be used for before ablation confirm ablation position.For example, temporary transient nerve block can blockade with The associated nerve of carotid body, this can cause to confirm that the position is probably for melting effective physiological effect.In addition, temporarily When nerve block can blockade preferably to be avoided and cause physiological effect (such as physiological effect can be by observing the eye of patient Eyeball, tongue, throat or facial muscles are noted by monitoring heart rate and the breathing of patient) important nerve, such as Vagus nerve, hypoglossal nerve or sympathetic nerve.This can alert the user position not in safe location.Similarly, do not deposit Indicating the physiological effect and the temporary transient nerve block of instruction carotid body nerve of these important neural temporary nerve blocks The combination of physiological effect may indicate that the position is in and melted for carotid body in safety and effective position.

Important nerve may be positioned close to target site and can damaged not inadvertently and inadvertently.Nerve thorn Swash or retardance may assist in before irreversible ablation occurs and determine these nerves in ablation areas.These nerves can wrap Include following：

Vagus nerve beam-vagus nerve is the neural beam for carrying difference in functionality, such as a) gill motor neuron is (special Internal organ spread out of (efferent special visceral)), it is responsible for swallowing and sounding and is distributed to rami pharyngei, god on larynx Through and nervus laryngeus inferior；B) Visceromotor neuron (common internal organ outflow), its be responsible for the control of unconscious muscle and body of gland and by It is distributed to heart, lung, oesophagus, stomach, solar plexus, and muscle and gastral body of gland；C) internal organ sensing god Through first (common somatic afferent volley), its be responsible for visceral sensitivity (visceral sensibility) and be distributed to uterine neck, Chest, belly fiber, and carotid body and aortic body；D) internal organ sensing neurones (special somatic afferent volley), it is negative Blame the sense of taste and be distributed to epiglottis and taste bud；E) common sensing neurones (common visceral afferent volley), it is responsible for cutaneous sensibility (cutaneous sensibility) and it is distributed to the auricular branch of external ear, duct and eardrum.Vagal dysfunction can To be detected by following：A) sound caused by neurotrosis changes (tongue when vagal damage can cause speech Motion failure, or voice are hoarse, if guiding the branch to larynx to be destroyed)；B) swallowed as caused by neurotrosis Difficult (vagus nerve controls many muscle in maxilla and tongue, and it is if that can be caused the difficulty swallowed by broken ring)；c) (pharyngeal reflex, which is controlled and damaged by vagus nerve, can lose this reflection, and this can increase by saliva for the change of pharyngeal reflex Or the risk choked of food)；D) (hearing loss can be because of the external ear to innervation ear for the hearing loss as caused by neurotrosis The damage of vagal branch cause)：E) (vagal damage can be with for the cardiovascular problem as caused by neurotrosis Cause cardiovascular side effect, including irregular heartbeat and arrhythmia cordis)；Or f) digestive problems as caused by neurotrosis (are confused The problem of contraction of stomach and intestines can be caused by walking the damage of nerve, this can cause constipation).

Superior laryngeal nerve-superior laryngeal nerve is the branch of vagus nerve beam.Functionally, superior laryngeal nerve function can be divided For sensitivities and motility part.Sense sexual function and a variety of input signals from supraglottic larynx head are provided.Motility work( It can relate to the power supply to ipsilateral cricothyreoideus.The contraction of cricothyreoideus makes lamina of cricoid cartilage be retreated at articulatio cricothyreoidea Tiltedly, cause the extension, tension and interior receipts (adduction) of vocal fold, cause caused pitch increase.The dysfunction of superior laryngeal nerve Pitch can be changed and cause that explosion sound can not be sent.The paralysis of bilateral is shown as tired and hoarse voice.

Cervical sympathetic nerve-cervical sympathetic nerve provides outflow to internal carotid nerve, external carotid nerves and superior cervical cardiac nerve Fiber.It provides the sympathetic nerve of head, neck and heart and dominated.By sympathetic nerve dominate organ include eyes, lachrymal gland and Salivary gland.The dysfunction of cervical sympathetic nerve includes bernard's syndrome, and it can fully identify and can include following Reaction：A) part ptosis (upper eyelid it is sagging, due to superior tarsalis, also referred to as Muller's muscle (M ü ller's Muscle the loss that sympathetic nerve) dominates)；B) (upside down ptosis, palpebra inferior slightly rise for inverted ptosis It is high)；C) anhidrosis (perspire and reduce on the side that face is affected)；D) myosis (small pupil, such as relative to will be by pupil Small or pupil contraction expected from the light quantity that hole receives extremely is less than two millimeters of diameter, or the receipts of the asymmetric side of pupil Contracting)；E) endophthalmos (marking that eyes sink)；F) ciliospinal reflex (ciliospinal reflex or pupillary-skin reflex, by ipsilateral Pupil in response to put on neck, face and upper trunk pain expansion form) loss.If the right side of neck is subjected to Pain stimulation, then right pupil expands about 1-2mm from baseline.It is this to be reflected in bernard's syndrome and be related to cervical sympathetic nerve fibre It is not present in the breakage of dimension.)

Summary：

Have already envisaged in the disease that is mediated with sympathetic nerve and the chemoreceptor reflex of enhancing (such as from carotid body To the high afferent nerve signals conduction of central nervous system, such as indicated in some cases by high peripheral chemical sensitiveness ) patient in by oriented energy ablation targets ablation site (such as peripheral chemoreceptor, carotid body), it is outer to reduce The input signal conduction of all chemosensitivities and reduction from peripheral chemoreceptor to central nervous system.In addition, set Want in the disease that is mediated with sympathetic nerve and the chemoreceptor reflex of enhancing (such as from carotid body to central nervous system High afferent nerve signals send, as in some cases by high peripheral chemical sensitiveness instruction) patient in pass through Through approach ablation targets ablation site (such as peripheral chemoreceptor, carotid body) in vein blood vessel, to reduce peripheral chemical The input signal conduction of sensitiveness and reduction from peripheral chemoreceptor to central nervous system.Chemoreceptor reflex activity Such as blood flow, blood CO are stimulated with to hypoxemia and others₂, concentration of glucose or blood pH the expected of sensitiveness subtract The input signal from chemocepter can be directly reduced less and produces at least one beneficial effect, such as maincenter is handed over Feel the reduction of psychoactive, the reduction of sensation of (expiratory dyspnea) of being short of breath, vasodilation, the increase of exercising ability, blood pressure Reallocation to skeletal muscle of reduction, the reduction, blood volume of sodium and water retention, the reduction of insulin resistance, hyperventilation The increase of reduction, the reduction of hypocapnia, the baroreflex of pressoreceptor and the pressure sensibility reduce, be short of breath, fan The increase of anxiety is walked, or improves the symptom of the disease of sympathetic nerve mediation, and can finally slow down progression of disease and extension Life-span.It should be understood that the disease that the sympathetic nerve of carotid body ablation can be used to mediate can be including elevated sympathetic tight , elevated sympathetic nerve/parasympathetic activity ratio, be mainly ascribable to central sympathetic anxiety singularly or undesirably High autonomic imbalance is attributable to traceable super to peripheral chemoreceptor (such as carotid body) at least in part Sensitive or hyperactive the incoming sympathetic tone increased excited.Certain that baseline hypocapnia wherein be present or be short of breath In a little important clinical cases, the reduction of hyperventilation and respiratory rate can be expected.It should be understood that in the context of this article Hyperventilation mean beyond individual metabolism need breathing, its typically result in slightly but significant hypocapnia (hypocapnea) (blood CO₂Partial pressure is below about 40mmHg normal value, such as in the range of 33 to 38mmHg).

Patient with the CHF or hypertension concurrent with elevated peripheral chemoreceptor activities and sensitiveness is frequent The reaction as their system is hypercarbia (although being not).The reaction usually for hyperventilation, from System removes CO₂Inadaptable trial, so as to overcompensation and the system that produces hypocapnia and alkalosis.Some researchers This supersensitivity/hyperactivity hyperkinesia of carotid body is attributed to the direct effect of catecholamines, catecholamines is in CHF The hormone excessively circulated in the blood flow of patient.The program may be useful for treating these patients, and the patient is because coming from The high anxiety of carotid body exports and produces hypocapnia and possible alkalosis.These patients are especially prone to periodically Low with the central apnea ventilation type event of breathing, these events cause to awaken, interference of sleeping, cause intermittence low-oxygen and It is that itself is harmful and difficult to treat.

It should be understood that Amur (Cheyne Stokes) type Cheyne-Stokes are used as to CO₂Maincenter hypersensitivity, to O₂With CO₂Peripheral chemical sensitiveness and extend circulation delay combination betide sleep, exercise and even rest during patient. All these parameters frequently exist in the CHF patient in high mortality risk.Therefore, with hypocapnia, CHF, height Chemosensitivity and the circulation delay extended patient, and when being especially presented on rest (rest) or during exercise or By the patient of the Cheyne-Stokes of hypoxia inducible, it may be possible to the beneficiary of proposed treatment.

Hyperventilation is defined as the breathing needed beyond people in the metabolism of preset time and activity level.Hyperventilation is more Specifically it is defined as exceeding CO₂Removed from blood with blood CO₂It is maintained in normal range (NR) (e.g., from about 40mmHg partial pressures) The ventilation volume per minute of required ventilation volume per minute.For example, with the arterial blood PCO in the range of 32-37mmHg₂'s Patient be considered hypocapnia and in the hyperventilation.

For the purpose of present disclosure, hyperventilation is equivalent to the different of carbon dioxide in the blood as caused by hyperventilation Often low level (such as hypocapnia (hypocapnia), hypocapnia (hypocapnea) or hypocapnia (hypocarbia)).Hyperventilation is with hypoventilation (such as hypoventilation) on the contrary, hypoventilation is often with lungs disease Occur in the patient of disease and cause level high (such as hypercarbia (hypercapnia) or the height of the carbon dioxide in blood Carbohemis (hypercarbia)).

Low carbon dioxide partial pressure in blood causes alkalosis, because CO₂It is acid and reduction CO in the solution₂ Make blood pH more alkaline, cause blood plasma calcium ion and the N＆M excitability reduced.The situation is in heart patient It is undesirable, because it can increase the probability of cardiac arrhythmia.

Alkalemia (Alkalemia) can be defined as blood basicity is abnormal or increased pH.Respiratory alkalosis be by The result of state, typically hyperventilation caused by body excessive loss carbon dioxide.The alkalosis of compensation is wherein to compensate The form that mechanism has normally been recovered pH directions.Realized for example, compensation can increase excretion bicarbonate by kidney.

The alkalosis compensated in rest is likely to become during exercise or as other results changed of metabolic balance It is uncompensated.Therefore, the method invented is applicable to the treatment of both uncompensated and compensation respiratory alkalosis.

It is short of breath and means quickly to breathe.For the purpose of present disclosure, exhaled for about 6 to 16 times per minute in rest The respiratory rate of suction is considered as normal, but the respiratory rate reduced in heart patient has known benefit.Breathing is anxious The reduction of rush can be expected reduction respiration dead space, increase the effciency of respiratory, and increase parasympathetic anxiety.

Treat embodiment：The effect of chemoreceptor reflex and central sympathetic activity in CHF

Development and progress of the chronic rise of sympathetic nerve activity (SNA) to certain form of hypertension are related and promote Into congestive heart failure (CHF) progress.It is also known that the excitatoty heart of sympathetic nerve, body and maincenter/ Peripheral chemoreceptor be reflected in CHF and hypertension by singularly strengthen (Ponikowski, 2011 and Giannoni, 2008 With 2009).

Arterial chemoreceptor plays important regulating and controlling effect in the control of aloveolar ventilation.They are also applied to cardiovascular function Add potent influence.

Oxygen (the O in human body₂) conveying and carbon dioxide (CO₂) removing by two control systems, Behavior- Based control and generation Thank to control and regulation.Metabolism ventilation control system drives our breathe and ensure point on pH, carbon dioxide in rest Press (PCO₂) and oxygen partial pressure (PO₂) optimum cell homeostasis.Metabolism control fine-tunes two groups of changes of function using providing Learn receptor：Central chemoreceptor and peripheral chemoreceptor such as sustainer chemistry in the ventral medulla of brain Receptor and chemical receptor of carotid body.Carotid body is one small avette (to be frequently described as the grain of rice (grain Of rice)) and very vascular organ, at carotid bifuracation in or its near, neck always moves at carotid bifuracation Arteries and veins branches into internal carotid (IC) and external carotid artery (EC).Central chemoreceptor is to hypercarbia (high PCO₂) sensitive, and And peripheral chemoreceptor is to hypercarbia and hypoxemia (low blood PO₂) sensitive.Under normal circumstances, sensor is by it The activation of respective stimulation cause to be intended to the rapid ventilation response for recovering cell homeostasis.

Early in 1868, Pfl ü ger recognized that hypoxemia stimulates ventilation, and this is excited for the sensitive acceptor of oxygen in big intracerebral And the research of the positioning at each position in peripheral circulation.When Corneille Heymans and his colleague observe, When flowing is reduced by the oxygen content of the blood of the bifurcated of arteria carotis communis, ventilation increase (won Nobel for him in 1938 Prize) when, being responsible for the searching for the oxygen chemical sensor that the ventilation to hypoxemia responds largely is considered as having completed.

In the hypoxemia under (after surgical operation removing) is not present of carotid chemoreceptor (such as carotid body) The persistence of stimulating effect causes other researchers (including Julius Comroe among them) anoxic chemical-sensitive Property is attributed to other positions, including periphery position (such as aortic body) and central brain position (such as hypothalamus, pons and Rostral ventrolateral medulla) the two.Aortic chemoreceptor in aortic body may be also the important chemistry of the mankind Receptor, there is material impact to vascular tone and cardiac function.

Chemical receptor of carotid body reflects：

Carotid body is a tuftlet chemocepter (also referred to as blood vessel glomus cell) and the bifurcated (fork) positioned at arteria carotis Medial surface near and the medial surface of bifurcated (fork) that be in most cases located directly in arteria carotis support cell, The bifurcated (fork) of arteria carotis extends along throat both sides.

These organs are used as different chemical stimulations of the detection from arterial blood and triggered in afferent fibre this Information is communicated to the sensor of the action potential of central nervous system (CNS).As response, CNS activation control hearts rate (HR), kidney The reflection of function and peripheral blood circulation, to keep blood gas O₂And CO₂With blood pH desired homeostasis.It is this to relate to And the closed loop control function of blood gas chemocepter is referred to as chemical receptor of carotid body reflection (CBC).Carotid body Chemoreceptor reflex is integrated in CNS together with the carotid sinus pressure reflection (CSB) for keeping arterial pressure.In the life of health In object, both reflections are maintained at blood pressure and blood gas in narrow physiological range.Chemical sensor in the arch of aorta For closed loop chemoreceptor reflex and baroreflex contributing redundant (redundancy) and work(is fine-tuned with pressure sensor handle Energy.In addition to sensing blood gas, carotid body is understood to be for blood flow and speed, blood Ph and grape now Sugared concentration sensitive.It will be understood, therefore, that in the disease of such as hypertension, CHF, insulin resistance, diabetes and other disturbed metabolisms In disease, the input signal conduction of carotid body nerve can be raised.Carotid body hyperactive, which is possibly even present in, not to be deposited In detectable hypersensitivity to hypoxemia and hypercarbia, hypoxemia and hypercarbia are traditionally used to indicate that carotid body Function.Therefore the purpose of proposed treatment is removing or reduces the afferent nerve signals from carotid body and reduce neck to move Contribution of the arteries and veins body to central sympathetic tone.

Carotid sinus pressure is reflected through the pressure sensor (such as pressoreceptor) for being incorporated with sensing arterial pressure Degeneration factor is realized.Pressoreceptor exists in other positions, such as sustainer and coronary artery.Important angiosthenia Ergoreceptor is located in carotid sinus, and carotid sinus is slightly expansion of the internal carotid 201 at its origin from arteria carotis communis Open structure.Carotid sinus baroreceptor separates close to carotid body but in anatomical structure with carotid body.Feeling of stress Receiver in response to arterial wall stretching, extension and blood pressure information is communicated to CNS.Pressoreceptor is distributed in the artery of carotid sinus In wall, and chemocepter (blood vessel glomus cell) gathering is in carotid body.This causes selectivity to reduce described in the application Chemoreceptor reflex be possibly realized, while substantially absolve baroreflex.

Carotid body shows the big sensitiveness (Low threshold and high harvest) to hypoxemia.In chronic congestive heart failure (CHF) in, it is therefore an objective to which heart can finally be aggravated by weakening the stomodaeal nervous system activation of whole body Low perfusion in CHF starting stage The progress of dysfunction, the progress of cardiac dysfunctions then increases extra heart abnormality, the positive feedback of progressive deterioration follows Ring, the vicious circle with negative consequence.Think, the increased major part of sympathetic nerve activity (SNA) is to be based on CNS in CHF The increase of horizontal sympathetic nerve flowing and the suppression based on arterial pressure reflection function.In the past few years, it has been shown that outer The enhancing that the increase (elevated chemoreceptor reflex function) of the activity and sensitiveness of all chemocepters also occurs in CHF SNA in play an important role.

Effect of the chemoreceptor reflex being changed in CHF：

As frequently in chronic disease states occurred, it is exclusively used in keeping homeostasis and correction under normal circumstances The sympathetic tone that the chemoreceptor reflex of hypoxemia is contributed in increase CHF patient, or even under the conditions of normoxic. Through obtained from multinomial zooscopy to the sensitiveness strengthened extremely of periphery chemical sensor particularly carotid body how tribute Offer in the understanding of the SNA tonicity rise (tonic elevation) in CHF patient.It is tight according to a theory, local vascular Plain receptor system is opened to play at all the chemical receptor of carotid body sensitiveness being enhanced in CHF.In addition, in CHF patient Clearly established with the evidence in both CHF animal models, chemical receptor of carotid body is reflected in CHF patient and passed through Be often hypersensitization and contribute to sympathetic nerve function tonicity rise.This entanglement derive from the incoming of reflex arc and The function being changed in the level of both central pathways.Cause the elevated incoming active mechanism from carotid body in CHF Not yet it is fully understood.

Regardless of the exact mechanism of carotid body hypersensitization behind, from carotid body and other autonomous path drives Chronic sympathetic activation causes the further deterioration of positive feedback loop cardiac function.When CHF then occurs, increase heart The seriousness of dysfunction causes these gradual gradually rise of change of chemical receptor of carotid body reflection function and enters one Step rise sympathetic activity and heart deteriorate.Triggering or the cause of disease for causing the cascade event to start in CHF development occurs The time-histories that factor and the cascade event occur is still unclear.However, causative factor is finally bundled in heart pump MSOF and the cardiac output of reduction.According to a theory, in carotid body, the gradual and chronic reduction of blood flow may It is the key for triggering the unconformable change of chemical receptor of carotid body reflection function generation in CHF.

There is ample evidence showing that there is increased periphery and central chemoreceptor reflection sensitive in heart failure Property, it may be related to the seriousness of disease.Also some evidences show that central chemoreceptor reflection is experienced by peripheral chemical Device Reflective regulation.According to current theory, carotid body is the significant contributor of the peripheral chemoreceptor reflection in the mankind；It is main Artery body has small contribution.

Although the mechanism for the central chemoreceptor reflex sensitivity for causing to change is still unclear, enhancing Peripheral chemoreceptor reflex sensitivity may produce with influenceing the nitric oxide of incoming sensitiveness in carotid body be suppressed with And influence the integrated maincenter Angiotensin II of maincenter of chemocepter input rise it is relevant.The chemocepter of enhancing Reflection can partly cause the breathing and the ventilation response of exercise, expiratory dyspnea, Amur in chronic heart failure of enhancing The sympathetic activation observed in patient.The ventilation when chemoreceptor reflex of enhancing can also result in rest and take exercise Spend and be short of breath (such as quickly breathing), take exercise, the periodic breathing during rest and sleep, hypocapnia, blood Pipe shrinks, the peripheral organ of reduction irrigates and hypertension.

Expiratory dyspnea：

It is short of breath or expiratory dyspnea be and the physical activity level of patient it is out-of-proportion expiratory dyspnea or laborious sense Feel.It is the symptom of a variety of different diseases or disorder and can be acute or chronic.Expiratory dyspnea is to suffer from cardiopulmonary The most common complaint of patient of disease.

Expiratory dyspnea be considered as due to Neurotransmission, breathing mechanics and central nervous system relevant response it Between complicated interaction.The specific region for the perception that may influence expiratory dyspnea property is recognized in midbrain.

It is dyspneic experience depending on its seriousness and it is potential the reason for.The sensation is in itself due to from lung, thoracic cavity, chest Nerve endings relaying (relay) in flesh or barrier film is incorporated in the pulse of brain with perception of the patient to the sensation and explanation Combination together.In some cases, the sensation being short of breath of patient is by the anxiety reinforcing on its reason.Patient is breathing Be described as to difficult diversity, make one it is uncomfortable it is short of breath, when moving chest muscle increased effort or fatigue impression, Tightening up in the panic sense to suffocate or the wall of the chest or the sensation of spasm.

Dyspneic four are to be based on its reason by generally accepted classification：Heart, lung, mixing it is heart or Lung and non-cardiac or non-lung.The most common dyspneic heart disease and tuberculosis of producing is asthma, pneumonia, COPD Ischaemic or heart attack (myocardial infarction) with cardiac muscle.Foreign-body aspiration, poisonous damage to air flue, pulmonary embolism, fill Courageous and upright heart failure (CHF), the anxiety (panic disorder) with hyperventilation, anaemia and because the body of the life style of sitting Deadaptation or obesity can produce expiratory dyspnea.In most of cases, have difficulty in breathing and add with potential disease Occur again.Expiratory dyspnea can also derive from weakness or damage, the lungs elasticity of reduction, the resistance of air flue of the wall of the chest or chest muscle Hinder, increased oxygen demand or cause increased pressure and fluid in lungs, such as poor heart pump action in CHF.

The acute dyspnea to break out is the common cause of emergency treatment.Most of cases of acute dyspnea are related to lung (lungs and breathing) disorderly, angiocardiopathy or thoracic trauma.Dyspneic (acute dyspnea) the most allusion quotation that breaks out It is associated type：Air flue narrow or air-flow hinder (bronchial spasm), lungs an artery in blockade (lung bolt Plug), acute heart failure or myocardial infarction, pneumonia or panic disorder.

Chronic respiratory difficulty is different.Long-standing expiratory dyspnea (chronic respiratory difficult) be most often lungs or Chronic or progressive disease the performance of heart, such as COPD, it includes chronic bronchitis and pulmonary emphysema.Chronic respiratory is stranded Difficult treatment depends on potential disorderly.Asthma can often use and reduce the drug therapy of airway spasm and be removed from patient environmental The former combination of disallergization is managed.COPD needs drug therapy, lifestyle change and long term body rehabilitation.Anxiety disorder is usual It is treated using drug therapy and therapeutive combination.

Although the exact mechanism having difficulty in breathing in different morbid states is disputable, no query is that CBC exists Played a role in the most performance of this symptom.Expiratory dyspnea seems most to generally occur in from peripheric receptor When incoming input is enhanced or when the cortex Oversensing of respiratory work.

The surgical operation of glomus removes and the excision of carotid body nerve：

For the surgical operation therapy of asthma, the removing (glomectomy) of carotid body or glomus, cured by Japanese surgery Raw Komei Nakayama describe in the 1940s.According to Nakayama, at him to 4,000 patients' with asthma In research, about 80% is cured or improves after the procedure and 58% claims and keeps good knot after 5 years for six months Fruit.Komei Nakayama have carried out his most of operations in Chiba universities during World War II.In 20 generation Record the later stage fifties, American surgeon doctor Overholt has carried out Nakayama operations to 160 U.S. patients.He feels It is required that two carotid bodies are removed only in three cases.He reports that some patients are in the wink being removed when carotid body Between or even earlier, when injection prevention activity of the carotid body by procaine (procaine hydrochloride), experience mitigation.

Overholt he described in the paper Glomectomy for Asthma that Chest is delivered in 1961 with Under mode surgical operation glomectomy:" in the broken line in neck, 1/3rd distances between angle of mandible and clavicle Place carries out two inch cuts.Platysma is divided and nutator is laterally retracted.Dissection carried out downwards to Arteria carotis sheath, exposure bifurcated.Superior thyroid artery is ligated and nearby splits to help neck at its edge (take-off) The inner side for rotating and exposing bifurcated of bulbus arteriosus.Carotid body is about the size of the grain of rice and to be hidden in outside the artery of blood vessel Film is interior and has identical color.Remove and be higher than one centimetre of bifurcated to outside less than the Perivascular artery of the centimeters of bifurcated one Film.Connection of this cut-out around the neuropile of carotid body.Adventitial dissection is required to position and identify arteria carotis Body.It is usually precisely positioned at bifurcated on the inside of it at point.Rarely, it can be in crotch (crotch) center or in outside It is found on wall.The parteriole of clamping, segmentation and ligation into carotid body.Then clamp, split and ligature on carotid body The upper handle of the tissue of side.”

In January nineteen sixty-five, New England Journal of Medicine have delivered the report of 15 cases, wherein In order to treat bronchial astehma unilateral removing Cervical Vessels ball (carotid body), but do not have target beneficial effect.This is effective Ground stopped the practice for being used to treat the glomectomy of asthma in the U.S..

Winter develops the technology of separation nerve, and the technology helps carotid sinus nerve being divided into two beams, arteria carotis Sinus (baroreflex) and carotid body (chemoreceptor reflex), and optionally cut off the latter.Winter technologies are to be based on His this discovery, the mainly lateral surface at carotid bifuracation and the carotid body (change of carotid sinus (baroreflex) nerve Learn receptor reflection) it is neural mainly in medial surface.

The nerve modulation of chemical receptor of carotid body reflection：

Hlavaka describes implantation electricity in the U.S. Patent Application Publication 2010/0070004 that August in 2009 is submitted on the 7th To apply electric signal, the electric signal blocks or suppresses to suffer from the chemocepter signal in dyspneic patient stimulator. Hlavaka is instructed, and " some patients can benefit from reactivation or adjust the ability of chemoreceptor function." Hlavaka concentrations In carotid body is connected to CNS neural conduction to carry out neural tune to chemoreceptor reflex by optionally blocking Section.Hlavaka is described using not changing or change carotid body tissue or the implantable electric pulse generator of chemocepter Nerve modulation conventional method.

Central chemoreceptor is located in brain and is difficult to approach.Peripheral chemoreceptor reflection is mainly easier to Close carotid body regulation.The 1940s and in the 1960s, before on operation go carotid body to treat The clinical practice of asthma has very limited amount of clinical success.

Claims (25)

1. a kind of supersonic melting conduit, including：

Supersonic melting transducer, Ultrasonic Diagnosis transducer and anechoic room, the supersonic melting transducer and the Ultrasonic Diagnosis Transducer is axially spaced and has fixed position, and the supersonic melting transducer relative to the Ultrasonic Diagnosis transducer It is arranged in the anechoic room.

2. supersonic melting conduit according to claim 1, in addition to the fluid being in fluid communication with the anechoic room convey Chamber.

3. supersonic melting conduit according to claim 1, wherein the anechoic room includes film and manifold, wherein described Manifold includes cavity.

4. supersonic melting conduit according to claim 1, wherein the Ultrasonic Diagnosis transducer includes surrounding the conduit Circumference set but the position opposite with the sighted direction of the supersonic melting transducer that is not arranged on the circumference it is more Individual ultrasonic imaging transducer.

5. supersonic melting conduit according to claim 1, wherein the Ultrasonic Diagnosis transducer includes surrounding the conduit Circumference set multiple ultrasonic imaging transducers.

6. supersonic melting conduit according to claim 5, in addition to be arranged on the supersonic melting conduit and led with described The opposite imaging artefacts of the sighted direction of pipe.

7. supersonic melting conduit according to claim 1, wherein the supersonic melting transducer is located at the Ultrasonic Diagnosis The distal end of transducer.

8. supersonic melting conduit according to claim 1, wherein the supersonic melting transducer is located at the Ultrasonic Diagnosis The near-end of transducer.

9. supersonic melting conduit according to claim 1, in addition to the expandable membrane with deployed condition, in the expansion In state, the expandable members diametrically prolong than outer catheter sheath to be projected farther.

10. supersonic melting conduit according to claim 1, wherein the anechoic room includes that there are multiple perforation therefrom to wear Saturating film.

11. supersonic melting conduit according to claim 1, in addition to guidewire lumen.

12. supersonic melting conduit according to claim 1, changed wherein the Ultrasonic Diagnosis transducer is rotary ultrasonic diagnosis Can device.

13. a kind of method that sighted direction to supersonic melting transducer is imaged, including

Supersonic melting conduit is provided, the supersonic melting conduit includes supersonic melting transducer and diagnostic ultrasound transducer, described Supersonic melting transducer is axially spaced with the diagnostic ultrasound transducer and has relative to the diagnostic ultrasound transducer solid Positioning is put；

Launch non-ablative ultrasonic signal from the supersonic melting transducer；With

The non-ablative ultrasonic signal and at least one anatomic marker are imaged with the diagnostic ultrasound transducer, so as to right The supersonic melting transducer is imaged for the sighted direction of at least one anatomic marker.

14. according to the method for claim 13, this method also includes disappearing to the diagnostic ultrasound transducer and the ultrasound Melt both transducers and send synchronizing signal.

15. according to the method for claim 13, wherein the supersonic melting transducer has and the diagnostic ultrasound transducing The different resonant frequency of device.

16. according to the method for claim 13, this method also includes rotating the supersonic melting transducer, until being launched Non-ablative signal be drawn towards destination organization.

17. according to the method for claim 13, wherein at least one anatomic marker be internal carotid, it is dynamic outside neck It is at least one in arteries and veins, carotid bifuracation and arteria carotis communis.

18. a kind of method of tissue with supersonic melting catheter ablation arteria carotis barrier film, including：

Supersonic melting conduit is provided, it includes diagnostic ultrasound transducer and supersonic melting transducer, the diagnostic ultrasound transducer It is axially spaced with the supersonic melting transducer and there is fixed position relative to the supersonic melting transducer；

The ablation catheter is positioned in patient's vascular system in the tube chamber of arteria carotis barrier film；

Produced using the diagnosing image transducer including at least one in arteria carotis communis bifurcated, internal carotid and external carotid artery The ultrasonoscopy of individual anatomic landmarks；

Confirm the supersonic melting transducer in the intraluminal ablation locations using the anatomic landmarks of imaging；And

When the supersonic melting transducer is in the ablation locations, by the supersonic melting from the supersonic melting transducer Tissue described in energy drag in arteria carotis barrier film is to melt the tissue in the arteria carotis barrier film and treat heart failure At least one of with hypertension.

19. according to the method for claim 18, wherein the diagnostic ultrasound transducer is in the supersonic melting transducer Near-end, and the ultrasonoscopy of anatomic marker is generated including the use of the diagnosing image using the diagnosing image transducer Transducer produces the ultrasonoscopy of arteria carotis communis bifurcated, and wherein confirms the supersonic melting using the anatomic marker of imaging Transducer confirms the supersonic melting transducing in the intraluminal ablation locations including the use of the arteria carotis communis bifurcated of imaging Device is in the intraluminal ablation locations.

20. according to the method for claim 18, wherein the diagnostic ultrasound transducer is in the supersonic melting transducer Distally, and using the diagnosing image transducer ultrasonoscopy of anatomic marker is generated including the use of the diagnosing image Transducer produces at least one ultrasonoscopy of internal carotid and external carotid artery, and wherein using the anatomic marker of imaging Confirm that the supersonic melting transducer comes really in the intraluminal ablation locations including the use of the arteria carotis of at least one imaging The supersonic melting transducer is recognized in the intraluminal ablation locations.

21. according to the method for claim 18, wherein the positioning step includes the ablation catheter being positioned in neck In one of vein or its tributary and at the arteria carotis barrier film, and wherein confirm institute using the anatomic marker of imaging State ablation catheter confirms the ablation catheter in institute in the intraluminal ablation locations including the use of the anatomic marker of imaging State the ablation locations in one of jugular vein or its tributary.

22. according to the method for claim 21, this method also includes by reconfiguring the jugular vein or its tributary One of in the conduit neck to be ablated is targetted closer to the arteria carotis barrier film with the movement supersonic melting transducer Artery diaphragm tissue.

23. according to the method for claim 18, this method is also included by rotating the supersonic melting transducing as needed Device is treated to be disappeared by the supersonic melting energy so that supersonic melting energy to be aimed at towards the tissue in the arteria carotis barrier film to target The arteria carotis diaphragm tissue melted.

24. according to the method for claim 23, wherein confirming that the supersonic melting changes using the anatomic marker of imaging Can device confirm the supersonic melting energy including the use of the anatomic marker of the imaging in the intraluminal ablation locations Sighted direction.

25. according to the method for claim 18, this method also includes by controlling supersonic melting energy transportation parameters come target To treating by the arteria carotis diaphragm tissue of the supersonic melting energy ablation.